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A Study In Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GSK523338
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes Type II

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2005
Last Updated
April 2, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00256867
Brief Title
A Study In Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 18, 2005 (Actual)
Primary Completion Date
October 31, 2006 (Actual)
Study Completion Date
October 31, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes Type II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
369 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GSK523338
Primary Outcome Measure Information:
Title
Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
Description
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.
Time Frame
Baseline (Week 0) and Week 6
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy
Description
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.
Time Frame
Baseline (Week 0) and Week 16
Title
Median Percent Change From Baseline to Week 6 in LDL-c
Description
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.
Time Frame
Baseline (Week 0) and Week 6
Title
Mean Change From Baseline to Week 16 in HbA1c
Description
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.
Time Frame
Baseline (Week 0) and Week 16
Title
Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)
Description
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.
Time Frame
Baseline (Week 0) and Week 16
Title
Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6
Description
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.
Time Frame
Week 6
Title
Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16
Description
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.
Time Frame
Up to Week 16
Title
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
Description
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.
Time Frame
Week 16
Title
On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate
Description
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.
Time Frame
Up to Week 16
Title
On-Therapy Change From Baseline in Body Weight
Description
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.
Time Frame
Up to Week 16
Title
Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine
Description
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.
Time Frame
Up to Week 16
Title
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Description
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.
Time Frame
Up to Week 16
Title
Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline
Description
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.
Time Frame
Up to Week 16

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVS101946
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVS101946
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVS101946
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVS101946
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVS101946
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVS101946
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AVS101946
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Study In Patients With Type 2 Diabetes Mellitus

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