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A New Oral Treatment For Type II Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00111800
First received: May 25, 2005
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW0823093
    Other Name: GW0823093
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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00111800     History of Changes
Other Study ID Numbers: DPB100925
Study First Received: May 25, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
NIDDM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013