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Completed

NCT Number: NCT00530309

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK716155 for injection

Drug

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.

Placebo

Drug

Subjects will also receive placebo.

Primary outcomes

  1. Plasma concentrations and PD parameters over time and at the end of study

    Time frame: Up to Week 9

Secondary outcomes

  1. Other metabolic parameters at the end of study

    Time frame: Up to Week 9

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 17, 2007
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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