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Completed

NCT Number: NCT00354536

In-patient Study With GSK716155 In Patients 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Miramar, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

GSK716155 subcutaneous injections

Drug

albiglutide subcutaneous injection

placebo injection

Biological

placebo injection

Other names: placebo

Primary outcomes

  1. blood plasma levels of GSK716155

    Time frame: on days 2 & 9

Secondary outcomes

  1. blood plasma levels of GSK716155

    Time frame: on days 2 & 9

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 20, 2006
Registry last updated
Oct 26, 2016

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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