Last updated: 11/04/2018 05:22:40

A Study In Patients With Type 2 Diabetes Mellitus

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GSK study ID
AVS101946
See study documents
Clinicaltrials.gov ID
NCT00256867
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2006-31-10
    Observational study model:
    Not applicable
    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
    • Inclusion criteria:
    • A clinical diagnosis type 2 diabetes mellitus.
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Brampton, Ontario, Canada, L6T 3T1
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sainte-Foy, Québec, Canada, G1V 1V6
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sainte-Foy, Québec, Canada, G1V 4G2
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Elkhart, Indiana, United States, 46515
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Columbia, South Carolina, United States, 29201
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99208
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 84 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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