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Efficacy and Safety of Alogliptin and Metformin Fixed-dose Combination in Patients With Type 2 Diabetes

Diabetes Mellitus Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin and Metformin Fixed Dose Combination, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).

Clinical Trial Description

The drug being tested in this study is a fixed-dose combination tablet of alogliptin and metformin to treat people who have diabetes. This study will look at glycemic control in people who take alogliptin and metformin FDC compared with alogliptin or metformin alone. The study will enroll approximately 640 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

- Alogliptin 12.5 mg twice daily (BID)

- Metformin HCL 500 mg BID

- Alogliptin 12.5 mg and Metformin HCL 500 mg FDC BID

- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take 2 tablets and 1 capsule twice a day at the same time each day throughout the study. All participants will be asked to record any hypoglycemic events in a diary. This multi-centre trial will be conducted in China, South Korea, and Malaysia. The overall time to participate in this study is 34 weeks. Participants will make 11 visits to the clinic. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01890122
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date September 2013
Completion date October 2015
View Details
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