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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Drug: exenatide Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide




Primary Outcome Measures :
  1. Pharmacodynamic measurements during 7 days of dosing.

Secondary Outcome Measures :
  1. Pharmacokinetic measurements during 7 days of dosing.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259896


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00259896     History of Changes
Other Study ID Numbers: GLP105330
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: January 2011

Keywords provided by GlaxoSmithKline:
exenatide
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists