Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Biological: albiglutide Biological: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Stepped Glucose Clamp Study to Assess the Effects of Albiglutide on Counter-regulatory Hormone Responses and Recovery From Hypoglycemia in Subjects With Type 2 Diabetes Mellitus.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Glucagon concentration (nmol/L) [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Glucagon concentration (nmol/L) during the hypoglycemic periods after treatment with albiglutide or placebo

Secondary Outcome Measures:

Plasma C-peptide concentration during hypoglycemic periods [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Insulin secretion rate (measured by mathematical analysis of C-peptide concentration) during the hypogycemic periods
Glucagon concentration [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Glucagon concentration at all stages of glycemia
Plasma C-peptide concentration during all stages of glycemia [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Insulin secretion rate (measured by mathematical analysis of C-peptide concentration) at all stages of glycemia
Albiglutide concentration [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Average concentration of albiglutide during the clamp period
Number of participants with adverse events [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Number of participants with adverse events during the clamp period

Enrollment:	41
Study Start Date:	December 2011
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: albiglutide single dose of albiglutide	Biological: albiglutide subcutaneous injection
Placebo Comparator: placebo single dose of placebo	Biological: placebo subcutaneous injection

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475734

Locations

United States, California
GSK Investigational Site
Chula Vista, California, United States, 91911

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01475734 History of Changes
Other Study ID Numbers:	108372
Study First Received:	November 17, 2011
Last Updated:	November 21, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

glucose clamp
hypoglycemia

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013