Dose Ranging Study of Albiglutide in Japanese Subjects

NCT01098461 | Completed Phase 2 Results DMC

• 1 other identifier: 110932
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 30

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

dose-ranging; pharmacokinetics; GSK716155; Japan; albiglutide

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16

  HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  Baseline and Week 16

Secondary Outcomes (8)

• Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16

  Baseline; Week 4, Week 8, Week 12, and Week 16

• Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16

  Baseline; Week 4, Week 8, Week 12, and Week 16

• Change From Baseline in Body Weight at Week 4, 8, 12, and 16

  Baseline; Week 4, Week 8, Week 12, and Week 16

• Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16

  Week 4, Week 8, Week 12, and Week 16

• Mean Clearance of Albiglutide

  Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24

Study Arms (4)

albiglutide 15mg weekly

ACTIVE COMPARATOR

once weekly subcutaneous injection of albiglutide 15mg

Biological: albiglutide

albiglutide 30mg weekly

ACTIVE COMPARATOR

once weekly subcutaneous injection of albiglutide 30mg

Biological: albiglutide

albiglutide 30mg every other week

ACTIVE COMPARATOR

subcutaneous injection of 30mg albiglutide every other week

Biological: albiglutide

placebo

PLACEBO COMPARATOR

once weekly subcutaneous injection of placebo to match albiglutide

Biological: placebo

Interventions

albiglutide BIOLOGICAL

subcutaneous injection of albiglutide

Also known as: placebo, albiglutide 30mg weekly, albiglutide 15mg weekly, albiglutide 30mg every other week

albiglutide 15mg weekly; albiglutide 30mg every other week; albiglutide 30mg weekly

placebo BIOLOGICAL

subcutaneous injection of placebo to match albiglutide

placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD
• BMI ≥18 kg/m2 and \<35 kg/m2 at Screening
• HbA1c between 7.0% and 10.0%, inclusive
• Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
• Female subjects of childbearing potential must be practicing adequate contraception .
• Able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor.
• Able and willing to provide written informed consent

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus
• Uncorrected thyroid dysfunction
• Previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening
• Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:
• Previous history of stroke or transient ischemic attack
• Active, unstable coronary heart disease within the past six months before Screening
• Documented myocardial infarction within one year before Screening
• Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before Screening
• Unstable angina
• Clinically significant arrhythmia or valvular heart disease
• Current heart failure NYHA class II to IV
• Resting systolic pressure \>160 mm Hg or diastolic pressure \>95 mm Hg at Screening
• ECG criteria at Screening
• Heart rate: \<40 and \>110 bpm
• PR interval: \<120 and \> 210 msec

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (30)

GSK Investigational Site

Aichi, 466-0815, Japan

Location

GSK Investigational Site

Ehime, 790-0067, Japan

Location

GSK Investigational Site

Fukuoka, 810-0001, Japan

Location

GSK Investigational Site

Fukuoka, 811-1346, Japan

Location

GSK Investigational Site

Fukuoka, 815-8555, Japan

Location

GSK Investigational Site

Fukuoka, 819-0168, Japan

Location

GSK Investigational Site

Hiroshima, 731-0103, Japan

Location

GSK Investigational Site

Hokkaido, 003-0023, Japan

Location

GSK Investigational Site

Hokkaido, 044-0053, Japan

Location

GSK Investigational Site

Hokkaido, 061-1395, Japan

Location

GSK Investigational Site

Hokkaido, 080-0010, Japan

Location

GSK Investigational Site

Hokkaido, 080-0016, Japan

Location

GSK Investigational Site

Ibaraki, 310-0826, Japan

Location

GSK Investigational Site

Ibaraki, 311-0113, Japan

Location

GSK Investigational Site

Kagoshima, 891-0401, Japan

Location

GSK Investigational Site

Kanagawa, 210-0852, Japan

Location

GSK Investigational Site

Kanagawa, 235-0045, Japan

Location

GSK Investigational Site

Kumamoto, 862-0976, Japan

Location

GSK Investigational Site

Kumamoto, 866-0862, Japan

Location

GSK Investigational Site

Miyagi, 980-0021, Japan

Location

GSK Investigational Site

Miyagi, 985-0852, Japan

Location

GSK Investigational Site

Nagasaki, 856-0831, Japan

Location

GSK Investigational Site

Saitama, 355-0321, Japan

Location

GSK Investigational Site

Saitama, 362-0021, Japan

Location

GSK Investigational Site

Tochigi, 329-0101, Japan

Location

GSK Investigational Site

Tochigi, 329-0433, Japan

Location

GSK Investigational Site

Tokyo, 125-0054, Japan

Location

GSK Investigational Site

Tokyo, 154-0015, Japan

Location

GSK Investigational Site

Tokyo, 177-0041, Japan

Location

GSK Investigational Site

Yamagata, 990-0885, Japan

Location

Related Publications (2)

• 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.

  PMID: 25387217 DERIVED

• Seino Y, Inagaki N, Miyahara H, Okuda I, Bush M, Ye J, Holland MC, Johnson S, Lewis E, Nakajima H. A randomized dose-finding study demonstrating the efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus. Curr Med Res Opin. 2014 Jun;30(6):1095-106. doi: 10.1185/03007995.2014.896327. Epub 2014 Mar 11.

  PMID: 24552155 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

rGLP-1 protein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: April 2, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 13, 2017
• Results First Posted: July 1, 2014

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (30)