A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM) - Full Text View

Purpose

This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Albiglutide 30 mg weekly Drug: Albiglutide 50 mg weekly Drug: Placebo Drug: Liraglutide 0.9 mg daily	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Liraglutide

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from Baseline at Week 24 of glycosylated hemoglobin (HbA1c). [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
The HbA1c will be assessed to compare two different doses of albiglutide with placebo. Change from baseline will be calculated as: HbA1c value at Week 24 minus HbA1c value at Baseline

Secondary Outcome Measures:

Change from baseline in HbA1c over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
HbA1c will be assessed through Week 52 to compare albiglutide and placebo.
The proportion of subjects at HbA1c goals of <6.5% and <7.0% over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
The proportion of subjects at HbA1c <6.5% and ,7.0% through Week 52 to compare albiglutide and placebo.
Change from Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
FPG will be assessed through Week 52 comparing albiglutide versus placebo
Change from baseline in body weight over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
Body weight will be assessed through Week 52 to compare albiglutide and placebo.
Time to withdrawal from randomly assigned treatment for any reason, and time to withdrawal from randomly assigned treatment due to hyperglycemia over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
Time to study treatment withdrawal will be assessed through Week 52 for any reason and for hyperglycemia to compare albiglutide and placebo.
Number of participants with adverse events [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
Comparison of number of participants with adverse events after treatment with albiglutide and placebo

Estimated Enrollment:	475
Study Start Date:	February 2013
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Albiglutide 30 mg weekly Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks	Drug: Albiglutide 30 mg weekly Albiglutide will be available as a pen injector that delivers 30mg of albiglutide Drug: Placebo Albiglutide matching placebo will be available as a pen injector
Experimental: Albiglutide 50 mg weekly Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52	Drug: Albiglutide 50 mg weekly Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
Placebo Comparator: Placebo Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52	Drug: Placebo Albiglutide matching placebo will be available as a pen injector
Active Comparator: Liraglutide 0.9 mg daily Subjects will be randomly assigned to open-label liraglutide for 52 weeks	Drug: Liraglutide 0.9 mg daily Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
Body mass index (BMI) 17 to 40 kg/ m2 inclusive
Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion Criteria:

History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or <6 weeks postpartum•
Clinically significant cardiovascular and/or cerebrovascular disease
Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
Prior use of a TZD or GLP-1R agonist within 4 months before Screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733758

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Locations

Japan
GSK Investigational Site	Recruiting
Gunma, Japan, 370-3573
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com
GSK Investigational Site	Not yet recruiting
Tochigi, Japan, 329-0433
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com
GSK Investigational Site	Not yet recruiting
Tokyo, Japan, 103-0027
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01733758 History of Changes
Other Study ID Numbers:	113121
Study First Received:	November 21, 2012
Last Updated:	May 9, 2013
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:

albiglutide
Japanese
GSK716155
Type 2 diabetes mellitus
glucagon-like peptide 1

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013