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

Phase 3

Completed

• Conditions: Health Condition 1: null- Diabetes Mellitus, Type 2

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

1. 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

1. 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