A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: CTRI/2010/091/001238
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study. Apart from India, other country participating in the study are Germany, Russia, Spain, UK, Israel, South Africa, USA, Brazil, Columbia, Peru, Australia, Philippines, South Korea, Taiwan. The number of subjects planned to be recruited from India is 50 and first subject enrollment was projected 30 Sep 2010. With very narrow gap in DCGI approval and global recruitment closure, no site from India could recruit any subject in India.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-05
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications 2.
• BMI more than or equal to 20kg per m2 and less than or equal to 45 kg per m2 3.
• Fasting C-peptide more than or equal to 0.8 ng per mL (more than or equal to 0.26 nmol per L) 4.
• HbA1c between 7.0 percent and 10.0 percent, inclusive 5.
• Female subjects of childbearing potential must be practicing adequate contraception.

Exclusion Criteria

• History of cancer 2.
• History of treated diabetic gastroparesis 3.
• Current biliary disease or history of pancreatitis 4.
• History of significant GI surgery 5.
• Recent clinically significant cardiovascular and/or cerebrovascular disease 6.
• Hypertension 7.
• History of human immunodeficiency virus infection 8.
• History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C 9.
• History of alcohol or substance abuse 10.
• Female subject is pregnant, lactating, or <6 weeks postpartum 11.
• Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast 12.
• History of type 1 diabetes mellitus Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide) 13.
• Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies 14.
• History or family history of thyroid disease Note: Subjects above the age of 65 years will not be enrolled in the study from India, as per Regulatory approval granted by Drugs Controller General of India (DCGI).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of change from baseline of HbA1c levels (representing glycemic efficacy) of albiglutide as compared with liraglutide.	Time Frame: 32 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in body weight	Time Frame: 32 weeks from baseline

Trial Locations

Locations (11)

Associate in Clinical Endocrinology Education and Research (ACEER); 🇮🇳 Chennai, TAMIL NADU, India

Bangalore Clinisearch; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Diabetes Hospital,; 🇮🇳 Bangalore, KARNATAKA, India

Chowpatty Medical Center; 🇮🇳 Mumbai, MAHARASHTRA, India

Endocare Clinic; 🇮🇳 Nashik, MAHARASHTRA, India

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

Health & Research Centre,; 🇮🇳 College, India

K G N Diabetes Research Institute; 🇮🇳 Mumbai, MAHARASHTRA, India

M. V. Hospital for Diabetes and Diabetes Research Centre,; 🇮🇳 Chennai, TAMIL NADU, India

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

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Associate in Clinical Endocrinology Education and Research (ACEER)

🇮🇳Chennai, TAMIL NADU, India

Dr. Usha Sriram

Principal investigator

aceer_chennai@yahoo.com