A Study In Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
369
6 countries
85
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Aug 2005
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 18, 2005
CompletedFirst Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2006
CompletedResults Posted
Study results publicly available
March 23, 2018
CompletedJuly 2, 2018
August 1, 2017
1.2 years
November 18, 2005
August 24, 2017
April 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.
Baseline (Week 0) and Week 6
Secondary Outcomes (12)
Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy
Baseline (Week 0) and Week 16
Median Percent Change From Baseline to Week 6 in LDL-c
Baseline (Week 0) and Week 6
Mean Change From Baseline to Week 16 in HbA1c
Baseline (Week 0) and Week 16
Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)
Baseline (Week 0) and Week 16
Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6
Week 6
- +7 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (85)
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Waterbury, Connecticut, 06708, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Saint Cloud, Florida, 34769, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Chicago, Illinois, 60607, United States
GSK Investigational Site
Melrose Park, Illinois, 60160, United States
GSK Investigational Site
Springfield, Illinois, 62704, United States
GSK Investigational Site
Avon, Indiana, 46123, United States
GSK Investigational Site
Elkhart, Indiana, 46515, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Waltham, Massachusetts, 02453, United States
GSK Investigational Site
City of Saint Peters, Missouri, 63376, United States
GSK Investigational Site
Billings, Montana, 59102, United States
GSK Investigational Site
Las Vegas, Nevada, 89103, United States
GSK Investigational Site
Jamaica, New York, 11432, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Columbus, Ohio, 43212, United States
GSK Investigational Site
Bend, Oregon, 97701, United States
GSK Investigational Site
Portland, Oregon, 97216, United States
GSK Investigational Site
Portland, Oregon, 97219, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Tualatin, Oregon, 97062, United States
GSK Investigational Site
Beaver, Pennsylvania, 15009, United States
GSK Investigational Site
Fleetwood, Pennsylvania, 19522, United States
GSK Investigational Site
Jefferson Hills, Pennsylvania, 15025, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19152, United States
GSK Investigational Site
Clinton, South Carolina, 29325, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Bryan, Texas, 77802, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Georgetown, Texas, 78626, United States
GSK Investigational Site
Midland, Texas, 79705, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
Salt Lake City, Utah, 84143, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
GSK Investigational Site
Manassas, Virginia, 20110, United States
GSK Investigational Site
Bellevue, Washington, 98004, United States
GSK Investigational Site
Spokane, Washington, 99208, United States
GSK Investigational Site
Vancouver, Washington, 98664, United States
GSK Investigational Site
Wollongong, New South Wales, 2500, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Keswick, South Australia, 5035, Australia
GSK Investigational Site
Port Lincoln, South Australia, 5606, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Heidelberg West, Victoria, 3081, Australia
GSK Investigational Site
Ringwood East, Victoria, 3135, Australia
GSK Investigational Site
Edmonton, Alberta, T5J 3N4, Canada
GSK Investigational Site
Edmonton, Alberta, T5N 3Y6, Canada
GSK Investigational Site
Coquitlam, British Columbia, V3K 3V9, Canada
GSK Investigational Site
Moncton, New Brunswick, E1G1A7, Canada
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 5R3, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3A 1Y8, Canada
GSK Investigational Site
Hamilton, Ontario, L8M 1K7, Canada
GSK Investigational Site
North Bay, Ontario, P1B 2H3, Canada
GSK Investigational Site
Toronto, Ontario, M3H 5S4, Canada
GSK Investigational Site
Toronto, Ontario, M8V 3X8, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Woodstock, Ontario, N4S 4G3, Canada
GSK Investigational Site
Bonaventure, Quebec, G0C 1E0, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Granby, Quebec, J2G 8Z9, Canada
GSK Investigational Site
Montreal, Quebec, H2K 4L5, Canada
GSK Investigational Site
Plessisville, Quebec, G6L 3J1, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 1V6, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 7H9, Canada
GSK Investigational Site
Guadalajara, Jalisco, 44340, Mexico
GSK Investigational Site
Cuernavaca, Morelos, 62420, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64570, Mexico
GSK Investigational Site
México, 14080, Mexico
GSK Investigational Site
Manila, 1008, Philippines
GSK Investigational Site
Quezon City, 1100, Philippines
GSK Investigational Site
Quezon City, 1113, Philippines
GSK Investigational Site
Carolina, 00983, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Study Start
August 18, 2005
Primary Completion
October 31, 2006
Study Completion
October 31, 2006
Last Updated
July 2, 2018
Results First Posted
March 23, 2018
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.