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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00256867
Registration number
NCT00256867
Ethics application status
Date submitted
18/11/2005
Date registered
22/11/2005
Date last updated
2/07/2018
Titles & IDs
Public title
A Study In Patients With Type 2 Diabetes Mellitus
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Scientific 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
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Secondary ID [1]
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AVS101946
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK523338
Treatment: Drugs: GSK523338
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Week 0) and Week 6
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Secondary outcome [1]
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Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy
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Assessment method [1]
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Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). 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 ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement.
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Timepoint [1]
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Baseline (Week 0) and Week 16
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Secondary outcome [2]
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Median Percent Change From Baseline to Week 6 in LDL-c
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Week 0) and Week 6
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Secondary outcome [3]
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Mean Change From Baseline to Week 16 in HbA1c
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Assessment method [3]
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Change from Baseline was computed as (Visit value - Baseline value). 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.
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Timepoint [3]
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Baseline (Week 0) and Week 16
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Secondary outcome [4]
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Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)
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Assessment method [4]
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Change from Baseline was computed as (Visit value - Baseline value). 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.
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Timepoint [4]
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Baseline (Week 0) and Week 16
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Secondary outcome [5]
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Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6
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Assessment method [5]
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Number of participants achieving American Diabetes Association (ADA) target of LDL<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.
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Timepoint [5]
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Week 6
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Secondary outcome [6]
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Number of Participants With HbA1c < 7.0% or Reduction of HbA1c = 0.7% at Week 16
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Assessment method [6]
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Number of participants achieving ADA target of HbA1c < 7.0% or reduction of HbA1c = 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.
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Timepoint [6]
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Up to Week 16
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Secondary outcome [7]
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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
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Assessment method [7]
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Number of participants achieving ADA target of FPG< 126 mg/dL (7.0 mmol/L) or reduction of FPG = 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate
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Assessment method [8]
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The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
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Timepoint [8]
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Up to Week 16
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Secondary outcome [9]
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On-Therapy Change From Baseline in Body Weight
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Assessment method [9]
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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. Change from Baseline was computed as: Visit value - Baseline Value.
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Timepoint [9]
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Up to Week 16
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Secondary outcome [10]
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Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine
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Assessment method [10]
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Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported.
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Timepoint [10]
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Up to Week 16
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Secondary outcome [11]
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Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
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Assessment method [11]
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AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
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Timepoint [11]
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Up to Week 16
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Secondary outcome [12]
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Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline
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Assessment method [12]
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The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.
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Timepoint [12]
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Up to Week 16
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/08/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/10/2006
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Sample size
Target
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Accrual to date
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Final
369
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Wollongong
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Recruitment hospital [2]
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GSK Investigational Site - Kippa Ring
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Recruitment hospital [3]
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GSK Investigational Site - Adelaide
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Recruitment hospital [4]
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GSK Investigational Site - Keswick
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Recruitment hospital [5]
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GSK Investigational Site - Port Lincoln
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Recruitment hospital [6]
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GSK Investigational Site - Box Hill
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Recruitment hospital [7]
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GSK Investigational Site - Heidelberg West
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Recruitment hospital [8]
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GSK Investigational Site - Ringwood East
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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4021 - Kippa Ring
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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5035 - Keswick
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Recruitment postcode(s) [5]
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5606 - Port Lincoln
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3081 - Heidelberg West
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Recruitment postcode(s) [8]
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3135 - Ringwood East
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Louisiana
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Newfoundland and Labrador
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Jalisco
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Morelos
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Nuevo León
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Manila
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Quezon City
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Carolina
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00256867
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00256867
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