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Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00394030
First received: October 27, 2006
Last updated: May 31, 2012
Last verified: March 2011
History of Changes

October 27, 2006
May 31, 2012
October 2006
March 2007   (final data collection date for primary outcome measure)
Pharmacokinetic measurements for different injection sites after one dose.
Same as current
Complete list of historical versions of study NCT00394030 on ClinicalTrials.gov Archive Site
Pharmacodynamic measurements at three different times after one dose.
Same as current
Not Provided
Not Provided
 
Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers
See Detailed Description

This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, 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.

An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2
Drug: GSK716155 subcutaneous injections
Other Name: GSK716155 subcutaneous injections
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).
  • Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.
  • Women must be of non-childbearing potential.

Exclusion criteria:

  • Bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dL)
  • Clinically significant hepatic enzyme elevation
  • HbA1c less than 6.5 or greater than 10
  • 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 prior to and during the in-patient clinic stays
  • Unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
  • 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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00394030
GLP107724
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP