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Alogliptin and pioglitazone: Drug information

Alogliptin and pioglitazone: Drug information
(For additional information see "Alogliptin and pioglitazone: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Congestive heart failure:

Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure (CHF) in some patients. After initiation and after dose increases, monitor patients carefully for signs and symptoms of heart failure (eg, excessive, rapid weight gain; dyspnea, edema). If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of alogliptin/pioglitazone must be considered.

Alogliptin/pioglitazone is not recommended in patients with symptomatic heart failure. Initiation in patients with established New York Heart Association (NYHA) class III or IV heart failure is contraindicated.

Brand Names: US
  • Oseni [DSC]
Pharmacologic Category
  • Antidiabetic Agent, Dipeptidyl Peptidase 4 (DPP-4) Inhibitor;
  • Antidiabetic Agent, Thiazolidinedione
Dosing: Adult

Dosage guidance:

Clinical considerations: May require a dose reduction of insulin secretagogues (eg, sulfonylureas, meglitinides) to avoid hypoglycemia; consider stopping insulin or reducing insulin dose (Ref).

Diabetes mellitus, type 2, treatment

Diabetes mellitus, type 2, treatment:

Note: Additional therapeutic considerations may apply; refer to individual agents for information. Discontinue use if signs or symptoms of heart failure develop (Ref). Due to lack of additive glycemic benefit, avoid use of alogliptin in combination with glucagon-like peptide-1 receptor agonist-based therapies (Ref).

Initial:

Patients not taking pioglitazone: Oral: Alogliptin 25 mg/pioglitazone 15 mg or alogliptin 25 mg/pioglitazone 30 mg once daily.

Patients taking pioglitazone: Oral: Alogliptin 25 mg per day plus current daily dose of pioglitazone given once daily.

Patients switching from individual alogliptin and pioglitazone formulations: Oral: Current dose of alogliptin and pioglitazone given once daily.

Dosage adjustment: May increase pioglitazone component in 15 mg/day increments every 4 to 12 weeks if needed to achieve glycemic goals (maximum: alogliptin 25 mg/pioglitazone 45 mg per day) (Ref).

Dosage adjustment with concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥60 mL/minute: No dosage adjustment necessary.

CrCl 30 to <60 mL/minute:

Patients not taking pioglitazone: Initial: Alogliptin 12.5 mg/pioglitazone 15 mg or alogliptin 12.5 mg/pioglitazone 30 mg once daily. Maximum: Alogliptin 12.5 mg/pioglitazone 45 mg once daily.

Patients taking pioglitazone: Initial: Alogliptin 12.5 mg daily plus current daily dose of pioglitazone given once daily. Maximum: Alogliptin 12.5 mg/pioglitazone 45 mg once daily.

Patients switching from individual alogliptin and pioglitazone formulations: Initial: Current dose of alogliptin and pioglitazone given once daily. Maximum: Alogliptin 12.5 mg/pioglitazone 45 mg daily.

CrCl <30 mL/minute, or ESRD: Use is not recommended. Appropriately adjusted dosage of individual components may be considered.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments for the combination product provided in the manufacturer's labeling. See individual agents.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. Also see individual agents.

1% to 10%:

Endocrine & metabolic: Hypoglycemia (≤4%)

Neuromuscular & skeletal: Back pain (4%)

Respiratory: Nasopharyngitis (5%), upper respiratory tract infection (4%)

Postmarketing:

Cardiovascular: Heart failure (including worsening of heart failure)

Gastrointestinal: Pancreatitis

Genitourinary: Bladder carcinoma (FDA Safety Alert, Dec. 19, 2016)

Neuromuscular & skeletal: Severe arthralgia (FDA Safety Alert, Aug 28, 2015)

Contraindications

History of serious hypersensitivity (eg, anaphylaxis, angioedema, severe dermatologic reactions) to products that contain alogliptin, pioglitazone, or any component of the formulation; initiation in patients with NYHA Class III or IV heart failure.

Warnings/Precautions

Concerns related to adverse effects:

• Arthralgia: Severe and disabling arthralgia has been reported with DPP-4 inhibitor use; onset may occur within one day to years after treatment initiation and may resolve with discontinuation of therapy. Some patients may experience a recurrence of symptoms if DPP-4 inhibitor therapy resumed. Discontinue use if severe joint pain results from DPP-4 inhibitor therapy.

• Bladder cancer: Clinical trial data is inconsistent regarding the risk of bladder cancer in patients exposed to pioglitazone. Given the uncertainty of the findings, the manufacturer recommends to avoid use in patients with active bladder cancer and consider risks versus benefits prior to initiating therapy in patients with a history of bladder cancer.

• Bullous pemphigoid: DPP-4 inhibitor use has been associated with development of bullous pemphigoid; cases have typically resolved with topical or systemic immunosuppressive therapy and discontinuation of DPP-4 inhibitor therapy. Advise patients to report development of blisters or erosions. Discontinue therapy if bullous pemphigoid is suspected and consider referral to a dermatologist.

• Edema: Dose-related edema, including new-onset or exacerbation of existing edema, has been reported with pioglitazone; use with caution in patients with edema or at risk for heart failure. Monitor for signs/symptoms of heart failure.

• Fractures: An increased incidence of bone fractures in females treated with pioglitazone has been observed; majority of fractures occurred in the lower limb and distal upper limb. Consider risk of fracture prior to initiation and during use.

• Heart failure/cardiac effects: [US Boxed Warning]: Thiazolidinediones, including pioglitazone, may cause or exacerbate heart failure (HF); closely monitor for signs and symptoms of HF (eg, rapid weight gain, dyspnea, edema), particularly after initiation or dose increases; if HF develops, treat accordingly and consider dose reduction of pioglitazone or discontinuation of alogliptin and pioglitazone. Monitor patients for signs and symptoms of HF (eg, dyspnea, edema, excessive/rapid weight gain). Not recommended for use in any patient with symptomatic HF. Initiation of therapy is contraindicated in patients with NYHA class III or IV heart failure; if used in patients with NYHA class I or II (systolic) HF, initiate at lowest dosage and monitor closely. In a multicenter, randomized, double-blind, placebo-controlled cardiovascular outcome trial of patients with type 2 diabetes and recent acute coronary syndrome, the overall incidence of hospitalization for HF was slightly greater in the alogliptin arm compared to placebo (3.9% vs 3.3%), but this difference was not statistically significant. In patients without a history of HF, the incidence of hospitalization for HF was greater with alogliptin than placebo (2.2% vs 1.3%), a difference that reached statistical significance (Zannad 2015). The American Diabetes Association suggests DPP-4 inhibitors (except saxagliptin) may be considered in patients with HF (ADA 2023).

• Hematologic effects: Pioglitazone may decrease hemoglobin/hematocrit; effects may be related to increased plasma volume.

• Hepatotoxicity: Cases of fatal and nonfatal hepatic failure have been reported in postmarketing surveillance. Baseline liver function tests (serum transaminases) are recommended to rule out underlying liver diseases. Use with caution in patients with abnormal serum transaminases. Monitor and promptly evaluate serum transaminase levels in patients with symptoms of hepatic injury (eg, fatigue, anorexia, jaundice, dark urine, and/or abdominal pain). In patients with clinically significant transaminase elevations and/or persistent or worsening elevations, therapy should be interrupted. Therapy should only be resumed with caution in patients where an alternative cause of transaminase elevations has been determined.

• Hypersensitivity reactions: Rare hypersensitivity reactions, including anaphylaxis, angioedema, and/or severe dermatologic reactions such as Stevens-Johnson syndrome, have been reported in postmarketing surveillance; discontinue if signs/symptoms of hypersensitivity reactions occur. Use with caution if patient has experienced angioedema with other DPP-4 inhibitor use.

• Pancreatitis: Cases of acute pancreatitis have been reported with use. Monitor for signs/symptoms of pancreatitis; discontinue use immediately if pancreatitis is suspected and initiate appropriate management. Use with caution in patients with a history of pancreatitis as it is not known if this population is at greater risk.

• Weight gain: Dose-related weight gain observed with use; mechanism unknown but likely associated with fluid retention and fat accumulation.

Disease-related concerns:

• Bariatric surgery:

– Altered absorption: Use individual components of the formulation after surgery. Absorption may be altered given the anatomic and transit changes created by gastric bypass and sleeve gastrectomy surgery (Mechanick 2020; Melissas 2013).

– Glucagon-like peptide-1 exposure and therapeutic efficacy: Closely monitor for signs and symptoms of pancreatitis; gastric bypass and sleeve gastrectomy may increase endogenous secretion of glucagon-like peptide-1 (Korner 2009; Peterli 2012). A single-dose, placebo-controlled study evaluated short-term therapy (4 weeks) with sitagliptin in gastric bypass patients having persistent or recurrent type 2 diabetes and found it to be well tolerated and provided a small but significant reduction in postprandial blood glucose (Shah 2018).

– Weight gain: Evaluate risk vs benefit and consider alternative therapy after gastric bypass, sleeve gastrectomy, and gastric banding; weight gain may occur (Apovian 2015).

• Hepatic impairment: Use with caution in patients with liver disease.

• Macular edema: Has been reported with thiazolidinedione use, including pioglitazone; some patients with macular edema presented with blurred vision or decreased visual acuity, and most had peripheral edema at time of diagnosis. Patients should be seen by an ophthalmologist if any visual symptoms arise during therapy and all diabetic patients should have regular eye exams.

• Renal impairment: Use with caution in patients with moderate renal dysfunction; dosing adjustment required. Not recommended in patients with severe renal dysfunction or end-stage renal disease (ESRD); appropriately adjusted dosage of individual components may be considered.

Other warnings/precautions:

• Appropriate use: Not for use in patients with diabetic ketoacidosis (DKA) or patients with type 1 diabetes mellitus.

• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Oseni: Alogliptin 25 mg and pioglitazone 15 mg [DSC], Alogliptin 25 mg and pioglitazone 30 mg [DSC], Alogliptin 25 mg and pioglitazone 45 mg [DSC], Alogliptin 12.5 mg and pioglitazone 15 mg [DSC], Alogliptin 12.5 mg and pioglitazone 30 mg [DSC], Alogliptin 12.5 mg and pioglitazone 45 mg [DSC]

Generic: Alogliptin 12.5 mg and pioglitazone 15 mg [DSC], Alogliptin 12.5 mg and pioglitazone 30 mg, Alogliptin 12.5 mg and pioglitazone 45 mg [DSC], Alogliptin 25 mg and pioglitazone 15 mg, Alogliptin 25 mg and pioglitazone 30 mg, Alogliptin 25 mg and pioglitazone 45 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Alogliptin-Pioglitazone Oral)

12.5-30 mg (per each): $7.80

25-15 mg (per each): $7.80

25-30 mg (per each): $7.80

25-45 mg (per each): $7.80

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: May be taken with or without food. Swallow tablets whole; do not split or divide.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf#page=42, must be dispensed with this medication.

Use: Labeled Indications

Diabetes mellitus, type 2, treatment: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abiraterone Acetate: May enhance the hypoglycemic effect of Thiazolidinediones. Risk C: Monitor therapy

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Dipeptidyl Peptidase-IV Inhibitors may enhance the adverse/toxic effect of Angiotensin-Converting Enzyme Inhibitors. Specifically, the risk of angioedema may be increased. Risk C: Monitor therapy

Beta-Blockers (Beta1 Selective): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May enhance the hypoglycemic effect of Antidiabetic Agents. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Bortezomib: May enhance the therapeutic effect of Antidiabetic Agents. Bortezomib may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

CYP2C8 Inducers (Moderate): May decrease the serum concentration of Pioglitazone. Risk C: Monitor therapy

CYP2C8 Inhibitors (Moderate): May increase the serum concentration of Pioglitazone. Risk C: Monitor therapy

CYP2C8 Inhibitors (Strong): May increase the serum concentration of Pioglitazone. Management: Limit the pioglitazone dose to 15 mg daily and monitor for increased pioglitazone toxicities (eg, hypoglycemia) when used in combination with strong CYP2C8 inhibitors. Risk D: Consider therapy modification

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Etilefrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Inhibitors of the Proton Pump (PPIs and PCABs): May enhance the adverse/toxic effect of Thiazolidinediones. Specifically, the risk of osteoporosis or fracture may be increased. Risk C: Monitor therapy

Insulins: Pioglitazone may enhance the adverse/toxic effect of Insulins. Specifically, the risk for hypoglycemia, fluid retention, and heart failure may be increased with this combination. Management: If insulin is combined with pioglitazone, consider insulin dose reductions to avoid hypoglycemia. Monitor patients for fluid retention and signs/symptoms of heart failure, and consider pioglitazone dose reduction or discontinuation if heart failure occurs Risk D: Consider therapy modification

Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor therapy

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Pregabalin: May enhance the fluid-retaining effect of Thiazolidinediones. Risk C: Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Sulfonylureas: Thiazolidinediones may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose adjustments in patients taking thiazolidinediones and monitor for hypoglycemia. Risk D: Consider therapy modification

Sulfonylureas: Dipeptidyl Peptidase-IV Inhibitors may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Topiramate: May decrease the serum concentration of Pioglitazone. Risk C: Monitor therapy

Reproductive Considerations

Pioglitazone may increase ovulation in premenopausal anovulatory patients resulting in unintended pregnancies.

Refer to individual monographs for additional information.

Pregnancy Considerations

Refer to individual monographs for information related to the treatment of diabetes mellitus in pregnancy.

Breastfeeding Considerations

It is not known if alogliptin or pioglitazone is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Refer to individual monographs for additional information.

Dietary Considerations

Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Monitoring Parameters

Serum glucose.

HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2023; KDIGO 2020).

Renal function (prior to initiation of therapy then annually or more frequent if necessary); liver enzymes (ALT, AST, alkaline phosphatase, and total bilirubin) prior to initiation in all patients (continue routine periodic monitoring during treatment in patients with liver disease or suspected liver disease).

Signs and symptoms of heart failure; weight gain; signs/symptoms of bladder cancer (dysuria, macroscopic hematuria, urinary urgency); ophthalmic exams.

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults with diabetes (AACE [Samson 2023], ADA 2023):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note : In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (SI: <10 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Older adults (≥65 years of age) (ADA 2023):

Note: Consider less strict targets in patients who are using insulin and/or insulin secretagogues (sulfonylureas, meglitinides) (LeRoith 2019).

HbA1c: <7% to 7.5% (healthy); <8% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (healthy); 90 to 150 mg/dL (SI: 5 to 8.3 mmol/L) (complex/intermediate health); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (very complex/poor health).

Bedtime capillary blood glucose: 80 to 180 mg/dL (SI: 4.4 to 10 mmol/L) (healthy); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (complex/intermediate health); 110 to 200 mg/dL (SI: 6.1 to 11.1 mmol/L) (very complex/poor health).

Classification of hypoglycemia (ADA 2023):

Level 1: 54 to 70 mg/dL (SI: 3 to 3.9 mmol/L); hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.

Level 2: <54 mg/dL (SI: <3 mmol/L); threshold for neuroglycopenic symptoms; requires immediate action.

Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.

Mechanism of Action

Alogliptin inhibits dipeptidyl peptidase 4 (DPP-4) enzyme resulting in prolonged active incretin levels. Incretin hormones (eg, glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]) regulate glucose homeostasis by increasing insulin synthesis and release from pancreatic beta cells and decreasing glucagon secretion from pancreatic alpha cells. Decreased glucagon secretion results in decreased hepatic glucose production. Under normal physiologic circumstances, incretin hormones are released by the intestine throughout the day and levels are increased in response to a meal; incretin hormones are rapidly inactivated by the DPP-4 enzyme.

Pioglitazone is a thiazolidinedione antidiabetic agent that lowers blood glucose by improving target cell response to insulin, without increasing pancreatic insulin secretion. It has a mechanism of action that is dependent on the presence of insulin for activity. Pioglitazone is a potent and selective agonist for peroxisome proliferator-activated receptor-gamma (PPARgamma). Activation of nuclear PPARgamma receptors influences the production of a number of gene products involved in glucose and lipid metabolism. PPARgamma is abundant in the cells within the renal collecting tubules; fluid retention results from stimulation by thiazolidinediones which increases sodium reabsorption.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Incresync;
  • (AT) Austria: Incresync;
  • (BR) Brazil: Nesina pio;
  • (CZ) Czech Republic: Incresync;
  • (EG) Egypt: Inhibazone;
  • (ES) Spain: Incresync;
  • (FI) Finland: Incresync;
  • (GB) United Kingdom: Incresync;
  • (GR) Greece: Incresync;
  • (HK) Hong Kong: Oseni;
  • (HR) Croatia: Incresync;
  • (HU) Hungary: Incresync;
  • (IE) Ireland: Incresync;
  • (IT) Italy: Incresync;
  • (JP) Japan: Liovel;
  • (KR) Korea, Republic of: Nesina act;
  • (KW) Kuwait: Incresync;
  • (LB) Lebanon: Incresync;
  • (LV) Latvia: Incresync;
  • (MX) Mexico: Incresina p;
  • (PR) Puerto Rico: Alogliptin and pioglitazone | Oseni;
  • (PT) Portugal: Incresync;
  • (QA) Qatar: Incresync;
  • (SA) Saudi Arabia: Incresync;
  • (SI) Slovenia: Incresync;
  • (SK) Slovakia: Incresync;
  • (TH) Thailand: Oseni;
  • (TW) Taiwan: Oseni
  1. American Diabetes Association (ADA). Standards of care in diabetes–2023. Diabetes Care. 2023;46(suppl 1):S1-S291. https://diabetesjournals.org/care/issue/46/Supplement_1. Accessed May 31, 2023.
  2. American Diabetes Association (ADA). Standards of medical care in diabetes–2021. Diabetes Care. 2021;44(suppl 1):S1-S232. https://care.diabetesjournals.org/content/44/Supplement_1. Accessed January 13, 2021.
  3. Apovian CM, Aronne LJ, Bessesen DH, et al; Endocrine Society. Pharmacological management of obesity: an Endocrine Society clinical practice guideline [published correction appears in J Clin Endocrinol Metab. 2015;100(5):2135-2136]. J Clin Endocrinol Metab. 2015;100(2):342-362. doi: 10.1210/jc.2014-3415 [PubMed 25590212]
  4. Davies MJ, D'Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41(12):2669‐2701. doi:10.2337/dci18-0033 [PubMed 30291106]
  5. FDA Safety Alert. DPP-4 Inhibitors. Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460238.htm. Accessed August 28, 2015.
  6. FDA Safety Alert. MedWatch. Pioglitazone-containing medicines: drug safety communication – updated FDA review, increased risk of bladder cancer. Food and Drug Administration website. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed December 19, 2016.
  7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm - 2020 executive summary. Endocr Pract. 2020;26(1):107-139. doi: 10.4158/CS-2019-0472. [PubMed 32022600]
  8. Inzucchi SE, Lupsa B. Thiazolidinediones in the treatment of type 2 diabetes mellitus. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 31, 2023.
  9. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int. 2020;98(supp 4):S1-S115. doi:10.1016/j.kint.2020.06.019 [PubMed 32998798]
  10. Korner J, Inabnet W, Febres G, et al. Prospective study of gut hormone and metabolic changes after adjustable gastric banding and Roux-en-Y gastric bypass. Int J Obes (Lond). 2009;33(7):786-795. doi: 10.1038/ijo.2009.79 [PubMed 19417773]
  11. LeRoith D, Biessels GJ, Braithwaite SS, et al. Treatment of diabetes in older adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2019;104(5):1520-1574. doi: 10.1210/jc.2019-00198. [PubMed 30903688]
  12. Mechanick JI, Apovian C, Brethauer S, et al. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures - 2019 update: cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, the Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Surg Obes Relat Dis. 2020;16(2):175-247. doi:10.1016/j.soard.2019.10.025 [PubMed 31917200]
  13. Melissas J, Leventi A, Klinaki I, et al. Alterations of global gastrointestinal motility after sleeve gastrectomy: a prospective study. Ann Surg. 2013;258(6):976-982. doi: 10.1097/SLA.0b013e3182774522. [PubMed 23160151]
  14. Nesto RW, Bell D, Bonow RO, et al. Thiazolidinedione use, fluid retention, and congestive heart failure: a consensus statement from the American Heart Association and American Diabetes Association. Diabetes Care. 2004;27(1):256-263. doi:10.2337/diacare.27.1.256 [PubMed 14693998]
  15. Oseni (alogliptin and pioglitazone) [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America Inc; March 2022.
  16. Peterli R, Steinert RE, Woelnerhanssen B, et al. Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: a randomized, prospective trial. Obes Surg. 2012;22(5):740-748. doi: 10.1007/s11695-012-0622-3. [PubMed 22354457]
  17. Refer to manufacturer's labeling.
  18. Samson SL, Vellanki P, Blonde L, et al. American Association of Clinical Endocrinology consensus statement: comprehensive type 2 diabetes management algorithm - 2023 update. Endocr Pract. 2023;29(5):305-340. doi:10.1016/j.eprac.2023.02.001 [PubMed 37150579]
  19. Shah A, Levesque K, Pierini E, et al. Effect of sitagliptin on glucose control in type 2 diabetes mellitus after Roux-en-Y gastric bypass surgery. Diabetes Obes Metab. 2018;20(4):1018-1023. doi: 10.1111/dom.13139 [PubMed 29072800]
  20. Zannad F, Cannon CP, Cushman WC, et al; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015;385(9982):2067-2076. doi: 10.1016/S0140-6736(14)62225-X. [PubMed 25765696]
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