NCT01777282|CompletedPhase 3Results

A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

116170

Study Type

interventional

Target

374

Locations

1 country

Sites

Timeline

RegisteredJan 2013

StartedFeb 2013

CompletionJan 2015

Brief Summary

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

374

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

Timeline

Completed

Started Feb 2013

Geographic Reach

1 country

49 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

January 24, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed

26 days until next milestone

Study Start

First participant enrolled

February 23, 2013

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2015

Completed

9 months until next milestone

Results Posted

Study results publicly available

October 14, 2015

Completed

Last Updated

May 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

January 24, 2013

Results QC Date

September 14, 2015

Last Update Submit

March 30, 2017

Conditions

Diabetes Mellitus

Keywords

albiglutideJapaneseglucagon-like peptide-1GSK716155

Outcome Measures

Primary Outcomes (2)

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.
From Baseline through Week 52
Number of Participants With Any Hypoglycemic Event
Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.
From Baseline through Week 52

Secondary Outcomes (5)

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
Baseline and Week 52
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)
Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Baseline and Week 52
Change From Baseline in Body Weight at Week 52
Baseline and Week 52
Time to Study Withdrawal Due to Hyperglycemia
Week 52

Study Arms (5)

Albiglutide + Sulfonylurea

ACTIVE COMPARATOR

Albiglutide in combination with background sulfonylurea

Drug: AlbiglutideDrug: Sulfonylurea

Albiglutide + Biguanide

ACTIVE COMPARATOR

Albiglutide in combination with background biguanide

Drug: AlbiglutideDrug: Biguanide

Albiglutide + Glinide

ACTIVE COMPARATOR

Albiglutide in combination with background glinide

Drug: AlbiglutideDrug: Glinide

Albiglutide + Thiazolidinedione

ACTIVE COMPARATOR

Albiglutide in combination with background thiazolidinedione

Drug: AlbiglutideDrug: Thiazolidinedione

Albiglutide + Alpha-glucosidase inhibitor

ACTIVE COMPARATOR

Albiglutide in combination with background alpha-glucosidase inhibitor

Drug: AlbiglutideDrug: Alpha-glucosidase inhibitor

Interventions

AlbiglutideDRUG

Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.

Albiglutide + Alpha-glucosidase inhibitorAlbiglutide + BiguanideAlbiglutide + GlinideAlbiglutide + SulfonylureaAlbiglutide + Thiazolidinedione

SulfonylureaDRUG