Dose Ranging Study of Albiglutide in Japanese Subjects

NCT ID: NCT01098461

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-05-31

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.

Detailed Description

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

albiglutide 15mg weekly

once weekly subcutaneous injection of albiglutide 15mg

Group Type: ACTIVE_COMPARATOR

albiglutide

Intervention Type: BIOLOGICAL

subcutaneous injection of albiglutide

albiglutide 30mg weekly

once weekly subcutaneous injection of albiglutide 30mg

Group Type: ACTIVE_COMPARATOR

albiglutide

Intervention Type: BIOLOGICAL

subcutaneous injection of albiglutide

albiglutide 30mg every other week

subcutaneous injection of 30mg albiglutide every other week

Group Type: ACTIVE_COMPARATOR

albiglutide

Intervention Type: BIOLOGICAL

subcutaneous injection of albiglutide

placebo

once weekly subcutaneous injection of placebo to match albiglutide

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

subcutaneous injection of placebo to match albiglutide

Interventions

albiglutide

subcutaneous injection of albiglutide

Intervention Type: BIOLOGICAL

placebo

subcutaneous injection of placebo to match albiglutide

Intervention Type: BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• QRS interval: <70 and >120 msec
• QTc interval (Bazett): >450 msec or >480 msec with bundle branch block
• Fasting triglyceride level >400 mg/dL at Screening
• AST or ALT >2xULN, ALP and bilirubin >1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin <35% of total bilirubin)
• If female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant
• Has significant renal disease as manifested by one or more of the following:

• Creatinine clearance at screening <60 mL/min (calculated by Cockcroft-Gault formula) at Screening
• Known loss of a kidney either by surgical ablation, injury or disease level
• A hemoglobinopathy that may affect determination of HbA1c level
• History of treated diabetic gastroparesis
• History of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function
• Current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis.
• Lipase and amylase at Screening > ULN
• Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma
• History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
• Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening
• Current and history of alcohol or substance abuse
• Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant
• Prior use of a GLP-1 analog
• Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation
• History of or family history of medullary carcinoma of the thyroid.
• History of or family history of multiple endocrine neoplasia type 2
• Receipt of any investigational drug within the 12 weeks before Screening

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Ehime, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Kagoshima, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kumamoto, , Japan

GSK Investigational Site

Kumamoto, , Japan

GSK Investigational Site

Miyagi, , Japan

GSK Investigational Site

Miyagi, , Japan

GSK Investigational Site

Nagasaki, , Japan

GSK Investigational Site

Saitama, , Japan

GSK Investigational Site

Saitama, , Japan

GSK Investigational Site

Tochigi, , Japan

GSK Investigational Site

Tochigi, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Yamagata, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 25387217 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24552155 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

110932

Identifier Type: -

Identifier Source: org_study_id