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

A Randomized, Double-Blind, Placebo- and Active-Controlled,Parallel-Group, Multicenter Study to Determine the Efficacy andSafety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000485

Enrollment

600

Registered

2009-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type - 2 Diabetes Mellitus

Interventions

Intervention1: Albiglutide: 30mg - 50mg, weekly subcutaneous injection Control Intervention1: Placebo: weekly subcutaneous injection

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. females who are pregnant, lactating, or less than 6 weeks post-partum 2. current symptomatic heart failure (NYHA Class II-IV)

Design outcomes

Primary

Measure	Time frame
HbA1c change from baselineTimepoint: Time Frame: one year	—

Secondary

Measure	Time frame
1. FPG change from baseline 2. body weight change from baselineTimepoint: Time Frame: one year	—

Countries

Argentina, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Mexico, Peru, Philippines, Republic of Korea, Russian Federation, South Africa, Spain, Taiwan, United Kingdom, United States of America

Contacts

Public ContactArun Sundriyal

GlaxoSmithKline Pharmaceuticals

jeroze.j.dalal@gsk.com912224959395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026