A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Type - 2 Diabetes Mellitus

• Registration Number: CTRI/2009/091/000485
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This randomized, double-blind, placebo- and active-controlled, 3 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide in combination with metformin and glimepiride compared with metformin plus glimepiride and placebo and metformin plus glimepiride and pioglitazone in subjects with type 2 diabetes mellitus. Subjects with type 2 diabetes mellitus whose glycemia is not adequately controlled with their current regimen of metformin plus a sulfonylurea will be recruited into the study. Subjects should be receiving at least 1500 mg of immediate release (IR) metformin daily, unless there is documentation that a lower dose is the subject?s maximum tolerated dose. Subjects must be receiving a sulfonylurea with a dose equivalent to 4 mg glimepiride. Subjects taking a sulfonylurea other than glimepiride will be switched to glimepiride during the Run-in/Stabilization Period. Subjects will continue taking IR metformin for the duration of their participation in the study. The study will comprise 4 study periods: Screening, Run-in/Stabilization, Treatment, and Posttreatment Follow-up. During the screening visit, informed consent and medical history will be obtained and subjects will undergo an eligibility assessment (complete physical examination, vital sign measurements, laboratory testing, electrocardiogram [ECG], standard urinalysis, pregnancy testing, drug screen, and serology screen). In addition, glycosylated hemoglobin (HbA1c) levels may be determined using a Metrika kit or other finger-stick procedure to provide a guideline for investigators on subject eligibility; the official HbA1c value that determines subject eligibility is measured by the central laboratory at the end of the Run-in/Stabilization Period (Visit 7). Fasting C-peptide is also measured at the screening visit and should be ≥0.8 ng/mL (≥0.26 nmol/L). Eligible subjects will be allowed to enter the 6-week Runin/ Stabilization Period. At the end of the Run-in/Stabilization Period, HbA1c is measured and the results must be between 7.0% and 10.0%, inclusive, for the subject to be eligible for the study. Eligible subjects will be stratified by HbA1c, based on the value obtained at Visit 7, (<8.0% versus ≥8.0%), history of prior myocardial infarction (MI) (yes versus no), and age (<65 years versus ≥65 years). Approximately 600 subjects will be randomly assigned to 1 of the following 3 treatment groups in a 5:5:2 ratio such that 1. Metformin + open-label glimepiride (4 mg daily) + pioglitazone (30 mg daily; treatment-masked uptitration if needed to 45 mg daily) + matching albiglutide placebo 2. Metformin + open-label glimepiride (4 mg daily) + pioglitazone matching placebo + albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) 3. Metformin + open-label glimepiride (4 mg daily) + pioglitazone matching placebo + albiglutide matching placebo The duration of the Treatment Period for the assessment of primary efficacy and safety is 52 weeks from the time of randomization, followed by an additional 104 weeks of. The participating countries apart from India in the trial are: Argentina, Brazil, Czech Republic, China, France, Germany, Hong-Kong, Korea, Mexico, Peru, Philippines, Russia South Africa, Spain, Taiwan, United Kingdom, USA. The number of patients proposed to be recruited from India is 60 with planned date of enrollment 01-Aug-2009. Screening of subjects closed on 13-Nov-2009 and total of 1442 patients were screened globally with 77 in India

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-11
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

• Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both 1.
• type 2 diabetes 2.
• BMI 20-45kg/m2 inclusive.

Exclusion Criteria

• females who are pregnant, lactating, or less than 6 weeks post-partum 2.
• current symptomatic heart failure (NYHA Class II-IV).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c change from baseline	Time Frame: one year

Secondary Outcome Measures

Name	Time	Method
1. FPG change from baseline2. body weight change from baseline	Time Frame: one year

Trial Locations

Locations (8)

Bangalore Clinisearch; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Diabetes Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dande Diabetes and Heart Care; 🇮🇳 Aurangabad, BIHAR, India

Diabetes Care and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Gokula Metropolis Clinical Research Center; 🇮🇳 Bangalore, KARNATAKA, India

KEM Hospital; 🇮🇳 Pune, MAHARASHTRA, India

M.V.Hospital for diabetes and Diabetic Research; 🇮🇳 Chennai, TAMIL NADU, India

Madras Diabetes Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

Bangalore Clinisearch

🇮🇳Bangalore, KARNATAKA, India

Dr. Paramesh Shamanna

Principal investigator

8025421333

dr_paramesh@hotmail.com