Phase 2 N=44 Randomized Quadruple-blind Treatment

Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT01475734 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure — 0.03780; 0.03805; 0.03780; 0.03780 Nanomoles per liter (nmol/L) — p=0.791

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: albiglutide (Biological); placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure	0.03780; 0.03805; 0.03780; 0.03780; 0.03783; 0.03780	0.791
SECONDARY Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period	0.22992; 0.15487; 0.32088; 0.22083; 0.02309; -0.00873	—
SECONDARY Epinephrine Values During the Glucose Clamp Period	56.9; 59.4; 60.7; 61.2; 57.8; 59.9	—
SECONDARY Norepinephrine Values During the Glucose Clamp Period	340.6; 357.0; 347.1; 360.9; 382.3; 376.2	—
SECONDARY Growth Hormone Values During the Glucose Clamp Period	0.29; 0.26; 0.17; 0.23; 0.16; 0.26	—
SECONDARY Insulin Values During the Glucose Clamp Period	140.5; 102.4; 297.5; 183.6; 385.9; 270.9	—
SECONDARY Cortisol Values During the Glucose Clamp Period	260.9; 282.9; 208.9; 250.5; 207.4; 272.3	—
SECONDARY C-peptide Values During the Glucose Clamp Period	1.095; 0.836; 1.616; 0.993; 1.630; 1.053	—
SECONDARY Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)	35.00; 30.00	—
SECONDARY Average Albiglutide Concentration on the Day of the Clamp Procedure	2110.5; 1968.7; 2039.63	—
SECONDARY Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period	9; 10; 0; 0	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01475734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.