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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354536
First received: July 18, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Non-Insulin-Dependent Diabetes Mellitus
 Drug: GSK716155 subcutaneous injections
Biological: placebo injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • blood plasma levels of GSK716155 [ Time Frame: on days 2 & 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood plasma levels of GSK716155 [ Time Frame: on days 2 & 9 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: albiglutide
albiglutide injection
 Drug: GSK716155 subcutaneous injections
albiglutide subcutaneous injection
Other Name: GSK716155 subcutaneous injections
Placebo Comparator: albiglutide placebo
placebo injection
 Biological: placebo injection
placebo injection
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354536

Locations
United States, Florida
GSK Investigational Site
Miramar, Florida, United States, 33025
GSK Investigational Site
Orlando, Florida, United States, 32809
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96814-4224
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00354536     History of Changes
Other Study ID Numbers: GLP106073
Study First Received: July 18, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK716155
albiglutide
pharmacodynamics
pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013