In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

October 24, 2016 updated by: GlaxoSmithKline

A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miramar, Florida, United States, 33025
        • GSK Investigational Site
      • Orlando, Florida, United States, 32809
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814-4224
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
  • Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
  • Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
  • Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
  • Women must be of non-childbearing potential.

Exclusion criteria:

  • Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL).
  • Clinically significant hepatic enzyme elevation.
  • Fasting plasma glucose greater than 240mg/dL.
  • Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
  • Any major illness other than diabetes.
  • Previous use of insulin as treatment for diabetes.
  • Significant renal disease as defined by screening lab tests.
  • History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
  • Smoking or use of nicotine-containing products within the previous 6 months.
  • History of alcohol or drug abuse.
  • Unwilling to abstain from alcohol during the study.
  • Unwilling to abstain from caffeine- or xanthine-containing products during the study.
  • Use of St. John's Wort during the study.
  • Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
  • Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: albiglutide
albiglutide injection
Drug: GSK716155 subcutaneous injections
albiglutide subcutaneous injection
Placebo Comparator: albiglutide placebo
placebo injection
Biological: placebo injection
placebo injection
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood plasma levels of GSK716155
Time Frame: on days 2 & 9
on days 2 & 9

Secondary Outcome Measures

Outcome Measure
Time Frame
blood plasma levels of GSK716155
Time Frame: on days 2 & 9
on days 2 & 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLP106073

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. Clinical Study Report
    Information identifier: GLP106073
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: GLP106073
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: GLP106073
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: GLP106073
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: GLP106073
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: GLP106073
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: GLP106073
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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