Last updated: 11/04/2018 05:22:40
A Study In Patients With Type 2 Diabetes Mellitus
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 16 week randomized, double-blind, parallel group study to evaluate the efficacy and safety of a new medication (GSK523338) to lower LDL-c and HbA1c in subjects with type 2 diabetes mellitus
Trial description: This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy
Timeframe: Baseline (Week 0) and Week 6
Secondary outcomes:
Mean change from Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV monotherapy
Timeframe: Baseline (Week 0) and Week 16
Median percent change from Baseline to Week 6 in LDL-c
Timeframe: Baseline (Week 0) and Week 6
Mean change from Baseline to Week 16 in HbA1c
Timeframe: Baseline (Week 0) and Week 16
Mean change from Baseline to Week 16 in Fasting Plasma Glucose (FPG)
Timeframe: Baseline (Week 0) and Week 16
Number of participant with LDL<100 mg/dL (2.59 mmol/L) at Week 6
Timeframe: Week 6
Number of participants with HbA1c < 7.0% or reduction of HbA1c ≥ 0.7% at Week 16
Timeframe: Up to Week 16
Number of participants with FPG< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16
Timeframe: Week 16
On-Therapy Vital Signs of Potential Clinical Concern including Systolic, Diastolic Blood Pressure and Heart Rate
Timeframe: Up to Week 16
On-Therapy change from Baseline in body weight
Timeframe: Up to Week 16
Number of Participants with Specified Ranges of Red and White Blood Cell Counts Detected in Urine
Timeframe: Up to Week 16
Number of participants with any adverse event (AE) and Serious adverse event (SAE)
Timeframe: Up to Week 16
Number of of participants with Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline
Timeframe: Up to Week 16
Interventions:
Drug: GSK523338
Enrollment:
369
Observational study model:
Not applicable
Primary completion date:
2006-31-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone, rosiglitazone/simvastatin, simvastatin
Collaborators
Not applicable
Study date(s)
August 2005 to October 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- A clinical diagnosis type 2 diabetes mellitus.
- Women must not be pregnant or breastfeeding during the study and 30 days after the study.
- Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement.
- Use of an investigational drug within 30 days or 5 half lives before first dose of study medication.
Inclusion and exclusion criteria
Inclusion criteria:
- A clinical diagnosis type 2 diabetes mellitus.
- Women must not be pregnant or breastfeeding during the study and 30 days after the study.
- Must sign an informed consent form at the study clinic.
Exclusion criteria:
- Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement.
- Use of an investigational drug within 30 days or 5 half lives before first dose of study medication.
- Insulin use for > 1 week in past 3 months.
Trial location(s)
Location
GSK Investigational Site
Elkhart, Indiana, United States, 46515
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99208
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97216
Status
Study Complete
Location
GSK Investigational Site
Carolina, Puerto Rico, Puerto Rico, 00983
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
St. Cloud, Florida, United States, 34769
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 7H9
Status
Study Complete
Location
GSK Investigational Site
Fleetwood, Pennsylvania, United States, 19522
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3V9
Status
Study Complete
Location
GSK Investigational Site
Saint Marc Des Carrieres, Québec, Canada, G0A 4B0
Status
Study Complete
Location
GSK Investigational Site
Clinton, South Carolina, United States, 29325
Status
Study Complete
Location
GSK Investigational Site
Jefferson Hills, Pennsylvania, United States, 15025
Status
Study Complete
Location
GSK Investigational Site
North Bay, Ontario, Canada, P1B 2H3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jamaica, New York, United States, 11432
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Status
Study Complete
Location
GSK Investigational Site
St. Peters, Missouri, United States, 63376
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Status
Study Complete
Location
GSK Investigational Site
Ringwood East, Victoria, Australia, 3135
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
Tualatin, Oregon, United States, 97062
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Washington, United States, 98004
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59102
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84143
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97219
Status
Study Complete
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
Waltham, Massachusetts, United States, 02453
Status
Study Complete
Location
GSK Investigational Site
Beaver, Pennsylvania, United States, 15009
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
Status
Study Complete
Location
GSK Investigational Site
Bend, Oregon, United States, 97701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
Status
Study Complete
Location
GSK Investigational Site
Manassas, Virginia, United States, 20110
Status
Study Complete
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Port Lincoln, South Australia, Australia, 5606
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G1A7
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Heidelberg West, Victoria, Australia, 3081
Status
Study Complete
Location
GSK Investigational Site
Vancouver, Washington, United States, 98664
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62704
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Keswick, South Australia, Australia, 5035
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-31-10
Actual study completion date
2006-31-10
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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