Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-07-31

Brief Summary

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This is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner.

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Detailed Description

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This is a Phase II, single-site, randomized, double-blind, parallel-group, placebo-controlled, stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given 3 days before employing a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner. In particular, this study is being conducted to ensure that albiglutide does not impair counter-regulatory responses during hypoglycemia.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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albiglutide

single dose of albiglutide

Group Type ACTIVE_COMPARATOR

albiglutide

Intervention Type BIOLOGICAL

subcutaneous injection

placebo

single dose of placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

subcutaneous injection

Interventions

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albiglutide

subcutaneous injection

Intervention Type BIOLOGICAL

placebo

subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening
* HbA1c \<10% at Screening for subjects who do not require washout of existing OAD or \<9% at Screening for subjects who do require washout from existing OAD
* Body mass index in range 28 kg/m2 to40 kg/m2

Exclusion Criteria

* History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
* History of significant gastrointestinal surgery,
* History of significant cardiovascular disease
* History of a seizure disorder
* Documented hypertension or hypotension
* Use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
* Current hepatic disease or abnormal liver function tests
* Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 1 or 2
* History of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
* Female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
* Known allergy to any GLP-1 analog or excipients of albiglutide, Baker's yeast, or insulin
* History of type 1 diabetes,
* Prior exposure to GLP-1 agents, including albiglutide
* Blood donation over 500 mL within 8 weeks before Screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Chula Vista, California, United States

Site Status

Countries

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United States

References

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Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

Reference Type DERIVED

PMID: 25387217 (View on PubMed)

Hompesch M, Jones-Leone A, Carr MC, Matthews J, Zhi H, Young M, Morrow L, Reinhardt RR. Albiglutide does not impair the counter-regulatory hormone response to hypoglycaemia: a randomized, double-blind, placebo-controlled, stepped glucose clamp study in subjects with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jan;17(1):82-90. doi: 10.1111/dom.12398. Epub 2014 Oct 26.

Reference Type DERIVED

PMID: 25263215 (View on PubMed)

Study Documents

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