Last updated: 11/04/2018 04:07:09
A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open-label trial to evaluate the safety and efficacy of fixed dose rosiglitazone/metformin combination therapy in poorly-controlled subjects with type 2 diabetes mellitus
Trial description: The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
190
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
October 2003 to November 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Laboratory result for HbA1c >11% or FPG >270mg/dL
- Clinical diagnosis of Type II diabetes
- Women who are pregnant
Inclusion and exclusion criteria
Inclusion criteria:
- Laboratory result for HbA1c >11% or FPG >270mg/dL
- Clinical diagnosis of Type II diabetes
- Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.
Exclusion criteria:
- Women who are pregnant
Trial location(s)
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Status
Study Complete
Location
GSK Investigational Site
North Bay, Ontario, Canada, P1B 2H3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-30-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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