A New Oral Treatment For Type II Diabetes Mellitus - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00111800

Purpose

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus	Drug: GW0823093	Phase II

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in HbA1c at Week 12.

Secondary Outcome Measures:

Change in HbA1c, FPG, fructosamine, insulin, pro-insulin, ECG, vital signs, BMI, waist/ hip circumference and weight.
Proportion of subjects who achieve predefined decreases or targets in HBA1c and FPG. PopPK. AEs, hypos and lab measures.

Estimated Enrollment:	366
Study Start Date:	April 2005

Detailed Description:

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.
Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111800

Show 101 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	DPB100925
Study First Received:	May 25, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00111800
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

NIDDM

Study placed in the following topic categories:

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

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009