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In-patient Study in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00259896
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

November 30, 2005
December 1, 2005
June 4, 2012
October 2005
Not Provided
Pharmacodynamic measurements during 7 days of dosing.
Same as current
Complete list of historical versions of study NCT00259896 on ClinicalTrials.gov Archive Site
Pharmacokinetic measurements during 7 days of dosing.
Same as current
Not Provided
Not Provided
 
In-patient Study in Patients With Type 2 Diabetes Mellitus
A Randomized, Open-label, Placebo-controlled, Repeat-dose Study to Assess the Pharmacokinetics and Pharmacodynamics of 5 Micrograms Exenatide Administered Subcutaneously Twice Daily for 7 Days in Healthy Normal Volunteers and in Subjects With Type 2 Diabetes Mellitus
This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2
Drug: exenatide
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
30
Same as current
Not Provided
Not Provided

Inclusion Criteria:

  • 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
  • must be willing to wash-out of these medications for 14 days prior to the start of the study
  • must have bloodwork that meets certain criteria (for example, total cholesterol < 240 mg/dL)

Exclusion Criteria:

  • must not have any other major illness other than diabetes
Sexes Eligible for Study: All
18 Years to 66 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00259896
GLP105330
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2011

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