A Study In Patients With Type 2 Diabetes Mellitus

April 2, 2018 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

369

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • GSK Investigational Site
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
      • Keswick, South Australia, Australia, 5035
        • GSK Investigational Site
      • Port Lincoln, South Australia, Australia, 5606
        • GSK Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • GSK Investigational Site
      • Heidelberg West, Victoria, Australia, 3081
        • GSK Investigational Site
      • Ringwood East, Victoria, Australia, 3135
        • GSK Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T5N 3Y6
        • GSK Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • GSK Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G1A7
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3T1
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8M 1K7
        • GSK Investigational Site
      • North Bay, Ontario, Canada, P1B 2H3
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3A 1Y8
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3H 5S4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M8V 3X8
        • GSK Investigational Site
      • Woodstock, Ontario, Canada, N4S 4G3
        • GSK Investigational Site
    • Quebec
      • Bonaventure, Quebec, Canada, G0C 1E0
        • GSK Investigational Site
      • Gatineau, Quebec, Canada, J8Y 6S8
        • GSK Investigational Site
      • Granby, Quebec, Canada, J2G 8Z9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2K 4L5
        • GSK Investigational Site
      • Plessisville, Quebec, Canada, G6L 3J1
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 1V6
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 4J6
        • GSK Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 7H9
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 14080
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • GSK Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62420
        • GSK Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64570
        • GSK Investigational Site
  • Philippines
      • Manila, Philippines, 1008
        • GSK Investigational Site
      • Quezon City, Philippines, 1113
        • GSK Investigational Site
      • Quezon City, Philippines, 1100
        • GSK Investigational Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • GSK Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85745
        • GSK Investigational Site
    • California
      • Fresno, California, United States, 93720
        • GSK Investigational Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
      • Saint Cloud, Florida, United States, 34769
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • GSK Investigational Site
      • Melrose Park, Illinois, United States, 60160
        • GSK Investigational Site
      • Springfield, Illinois, United States, 62704
        • GSK Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • GSK Investigational Site
      • Elkhart, Indiana, United States, 46515
        • GSK Investigational Site
    • Louisiana
      • Sunset, Louisiana, United States, 70584
        • GSK Investigational Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • GSK Investigational Site
    • Missouri
      • Saint Peters, Missouri, United States, 63376
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59102
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • GSK Investigational Site
    • New York
      • Jamaica, New York, United States, 11432
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43212
        • GSK Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • GSK Investigational Site
      • Portland, Oregon, United States, 97239
        • GSK Investigational Site
      • Portland, Oregon, United States, 97216
        • GSK Investigational Site
      • Portland, Oregon, United States, 97219
        • GSK Investigational Site
      • Tualatin, Oregon, United States, 97062
        • GSK Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • GSK Investigational Site
      • Fleetwood, Pennsylvania, United States, 19522
        • GSK Investigational Site
      • Jefferson Hills, Pennsylvania, United States, 15025
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19152
        • GSK Investigational Site
    • South Carolina
      • Clinton, South Carolina, United States, 29325
        • GSK Investigational Site
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
    • Texas
      • Bryan, Texas, United States, 77802
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Georgetown, Texas, United States, 78626
        • GSK Investigational Site
      • Midland, Texas, United States, 79705
        • GSK Investigational Site
      • Plano, Texas, United States, 75093
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • GSK Investigational Site
      • Manassas, Virginia, United States, 20110
        • GSK Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • GSK Investigational Site
      • Spokane, Washington, United States, 99208
        • GSK Investigational Site
      • Vancouver, Washington, United States, 98664
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
Time Frame: Baseline (Week 0) and Week 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy
Time Frame: Baseline (Week 0) and Week 16
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.
Baseline (Week 0) and Week 16
Median Percent Change From Baseline to Week 6 in LDL-c
Time Frame: Baseline (Week 0) and Week 6
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.
Baseline (Week 0) and Week 6
Mean Change From Baseline to Week 16 in HbA1c
Time Frame: Baseline (Week 0) and Week 16
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.
Baseline (Week 0) and Week 16
Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)
Time Frame: Baseline (Week 0) and Week 16
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.
Baseline (Week 0) and Week 16
Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6
Time Frame: Week 6
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.
Week 6
Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16
Time Frame: Up to Week 16
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.
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
Time Frame: Week 16
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.
Week 16
On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate
Time Frame: Up to Week 16
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.
Up to Week 16
On-Therapy Change From Baseline in Body Weight
Time Frame: Up to Week 16
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.
Up to Week 16
Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine
Time Frame: Up to Week 16
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.
Up to Week 16
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Time Frame: Up to Week 16
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.
Up to Week 16
Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline
Time Frame: Up to Week 16
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.
Up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2005

Primary Completion (Actual)

October 31, 2006

Study Completion (Actual)

October 31, 2006

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVS101946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: AVS101946
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: AVS101946
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: AVS101946
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: AVS101946
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: AVS101946
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: AVS101946
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: AVS101946
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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