In-Patient Study in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00259896

Purpose

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	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide	Phase I

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Pharmacodynamic measurements during 7 days of dosing.

Secondary Outcome Measures:

Pharmacokinetic measurements during 7 days of dosing.

Estimated Enrollment:	30
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259896

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	GLP105330
Study First Received:	November 30, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00259896
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

exenatide
pharmacodynamics
pharmacokinetics

Study placed in the following topic categories:

Metabolic Diseases
Exenatide
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Healthy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009