A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by Alogliptin and Metformin Therapy

• Status: Recruiting
• Trial end date: 2022-02-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 52.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celltrion Pharm, Inc.; Takeda
• Treatments: Alogliptin; Dapagliflozin; Glimepiride; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

1. Is a regular outpatient with an historical diagnosis of type 2 diabetes.

2. Has metabolic syndrome as jointly defined by the International Diabetes Federation (IDF); National Heart, Lung, and Blood Institute (NHLBI) / American Heart Association (AHA); and International Association for the Study of Obesity (IASO). If any 3 of the following 5 risk factors are present, metabolic syndrome can be considered:

• High waist circumference: male >=90 centimeter (cm), female >=85 cm.

• High TGs (drug treatment for high TGs is an alternate indicator): >=150 mg/dL (1.7 millimole per liter [mmol/L]).

• Low HDL-C (drug treatment for low HDL-C is an alternate indicator): <40 mg/dL (1.0 mmol/L) in males, <50 mg/dL (1.3 mmol/L) in females.

• High blood pressure (antihypertensive drug treatment in a participant with a history of hypertension is an alternate indicator): Systolic >=130 millimeter of mercury (mmHg) and/or diastolic >=85 mmHg.

• High fasting glucose (drug treatment of high glucose is an alternate indicator):

>= 100 mg/dL.

3. Has been receiving a stable dose of alogliptin + metformin therapy with diet and exercise for >=3 months prior to randomization.

4. Has a HbA1c value between 7.0 to 11% inclusively within 7 days of randomization via central laboratory test.

Exclusion Criteria:

1. Has received thiazolidinedione (TZD) or sodium-glucose co-transporter-2 (SGLT-2) inhibitor within 6 months prior to randomization.

2. Has type 1 diabetes, diabetic ketoacidosis, diabetic coma or diabetic pre-coma.

3. The use of any medications that is, oral or systemically injected glucocorticoids (including intra-articular injection), weight-loss drugs, insulin or other anti-diabetic drugs except alogliptin and metformin, within 3 months prior to randomization. Strong Cytochrome P450 2C8 (CYP2C8) inhibitors (example, gemfibrozil, montelukast, quercetin, phenelzine) and CYP2C8 inducers (example, rifampin) that in the opinion of the Investigator or Sponsor require treatment contraindicated during the study. The diuretics, angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) -inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs) are to be used per product label with close monitoring under Investigator's supervision.

4. Has genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder, etc.

5. Has a history of alcohol abuse within 2 years prior to randomization.