Alogliptin compared to Glipizide with Metformin in Type 2 Diabetes
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination with Metformin in Subjects with Type 2 Diabetes
IRAS ID
17721
Sponsor organisation
Takeda Global Research & Development Centre, (Europe)Ltd.
Eudract number
2008-007444-34
Clinicaltrials.gov Identifier
Research summary
For patients with type 2 diabetes mellitus (T2DM), metformin is the usual first-line oral therapy in addition to diet control and exercise. If metformin does not adequately control the diabetes or if there are serious side effects, sulphonylurea is a popular second-line choice of oral anti-diabetic treatment. Alogliptin is an investigational medicine being developed to improve blood glucose control in people with T2DM. Alogliptin controls blood glucose by making the good effects of GLP-1 last longer. GLP-1 is a natural substance released by the body from the gut after meals. This leads to more insulin release.Alogliptin has already been tested in a large number of T2DM patients and has so far been safe, effective and did not lead to weight gain. This research study will assess the safety and effectiveness of alogliptin plus metformin, as compared with glipizide (sulphonylurea) plus metformin over a longer treatment period.Adults aged 18-80 years inclusive, currently taking metformin with inadequate glucose control, will be invited to participate. Depending on their metformin dose and blood glucose control, they will enter a screening period of 6-16 weeks. Eligible participants will then be randomised to receive either glipizide 5 mg/day, alogliptin 12.5mg/day or alogliptin 25mg/day in addition to metformin. The study is double-blind, meaning that neither the participant nor the doctor will know which treatment group has been assigned. Participants will receive study medication for 2 years.Participants will complete between 21 and 32 visits. Procedures that participants will undergo include: physical examination, vital signs, electrocardiogram, blood and urine collection, complete diaries and questionnaires and measure blood sugar levels using a glucometer.This study is sponsored by Takeda; a maximum of 2691 participants will be enrolled worldwide.
REC name
London - City & East Research Ethics Committee
REC reference
09/H0703/66
Date of REC Opinion
11 Jun 2009
REC opinion
Further Information Favourable Opinion