A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: sitagliptin; Biological: albiglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01098539

114130

Details and patient eligibility

About

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Full description

This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Enrollment: 507 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
• BMI >/=20 kg/m2 and </=45 kg/m2
• Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
• HbA1c between 7.0% and 10.0%, inclusive.

Exclusion criteria

• History of cancer
• History of treated diabetic gastroparesis
• Current biliary disease or history of pancreatitis
• History of significant gastrointestinal surgery
• Recent clinically significant cardiovascular and/or cerebrovascular disease
• History of human immunodeficiency virus infection
• Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
• Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
• Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
• Receipt of any investigational drug or sitagliptin 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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507 participants in 2 patient groups

albiglutide

Active Comparator group

Description:

albiglutide weekly subcutaneous injection + sitagliptin matching placebo

Treatment:

Biological: albiglutide

sitagliptin

Active Comparator group

Description:

albiglutide matching placebo + sitagliptin

Treatment:

Drug: sitagliptin