Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus -A Phase I/II Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of GSK716155 in Japanese Subjects With Type 2 Diabetes Mellitus

A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: GSK716155 for injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • GSK Investigational Site
  • Tokyo, Japan, 160-0017
    • GSK Investigational Site
  • Tokyo, Japan, 130-0004
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Type 2 diabetes mellitus diagnosed at least 3 months with FPG level <=240mg/dL and HbA1c between 6.5% and 10% inclusive.
• Must be diet controlled - OR - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
• Must have a BMI:<=35kg/m2, 20 to 70 years of age inclusive.
• Woman must be of non-childbearing potential.

Exclusion criteria:

• Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
• Clinically significant hepatic enzyme elevation.
• History of metabolic disease other than T2DM.
• Previous use of insulin as a treatment for diabetes within 3 months.
• History of severe gastrointestinal disease.
• Clinically significant cardiovascular disease.
• Significant renal disease as defined by screening lab test.
• History of drug (including albumin or albumin containing agents) allergy.
• History of alcohol or drug abuse.
• Donation of blood in excess of 400mL within previous 4 months.
• Previously received any GLP-1 mimetic or any other albumin-containing products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects receiving GSK716155 + placebo; Eligible subjects will receive GSK716155 with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. Subjects will also receive placebo.	Drug: GSK716155 for injection; GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.; Drug: Placebo; Subjects will also receive placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations and PD parameters over time and at the end of study	Up to Week 9

Secondary Outcome Measures

Outcome Measure	Time Frame
Other metabolic parameters at the end of study	Up to Week 9

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• Seino Y, Nakajima H, Miyahara H, Kurita T, Bush MA, Yang F, Stewart MW. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin. 2009 Dec;25(12):3049-57. doi: 10.1185/03007990903372999.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): April 17, 2008
• Study Completion (Actual): April 17, 2008

Study Registration Dates

• First Submitted: September 14, 2007
• First Submitted That Met QC Criteria: September 14, 2007
• First Posted (Estimate): September 17, 2007

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: tolerability; safety; GLP-1; pharmacokinetics; pharmacodynamics; type 2 diabeted mellitus; GSK716155; GLP-1 receptor agonist
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GLP107865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: GLP107865
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: GLP107865
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: GLP107865
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: GLP107865
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: GLP107865
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: GLP107865
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: GLP107865
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register