A Study In Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256867
• Other study ID #: AVS101946
• Status: Completed
• Phase: Phase 3
• Start date: August 18, 2005
• Est. completion date: October 31, 2006

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: October 31, 2006
• Est. primary completion date: October 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GSK523338

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Heidelberg West	Victoria
Australia	GSK Investigational Site	Keswick	South Australia
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Port Lincoln	South Australia
Australia	GSK Investigational Site	Ringwood East	Victoria
Australia	GSK Investigational Site	Wollongong	New South Wales
Canada	GSK Investigational Site	Bonaventure	Quebec
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Coquitlam	British Columbia
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Granby	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Moncton	New Brunswick
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Mount Pearl	Newfoundland and Labrador
Canada	GSK Investigational Site	North Bay	Ontario
Canada	GSK Investigational Site	Plessisville	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Saint Marc Des Carrieres	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Woodstock	Ontario
Mexico	GSK Investigational Site	Cuernavaca	Morelos
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Puerto Rico	GSK Investigational Site	Carolina
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Avon	Indiana
United States	GSK Investigational Site	Beaver	Pennsylvania
United States	GSK Investigational Site	Bellevue	Washington
United States	GSK Investigational Site	Bend	Oregon
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Bryan	Texas
United States	GSK Investigational Site	Burke	Virginia
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Clinton	South Carolina
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Elkhart	Indiana
United States	GSK Investigational Site	Fleetwood	Pennsylvania
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Georgetown	Texas
United States	GSK Investigational Site	Jamaica	New York
United States	GSK Investigational Site	Jefferson Hills	Pennsylvania
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Manassas	Virginia
United States	GSK Investigational Site	Melrose Park	Illinois
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Midland	Texas
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Saint Cloud	Florida
United States	GSK Investigational Site	Saint Peters	Missouri
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Tualatin	Oregon
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Vancouver	Washington
United States	GSK Investigational Site	Waltham	Massachusetts
United States	GSK Investigational Site	Waterbury	Connecticut
United States	GSK Investigational Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Mexico,  Philippines,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (Week 0) and Week 16
Secondary	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.	Baseline (Week 0) and Week 6
Secondary	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.	Baseline (Week 0) and Week 16
Secondary	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.	Baseline (Week 0) and Week 16
Secondary	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.	Week 6
Secondary	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.	Up to Week 16
Secondary	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.	Week 16
Secondary	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.	Up to Week 16
Secondary	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.	Up to Week 16
Secondary	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.	Up to Week 16
Secondary	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.	Up to Week 16
Secondary	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.	Up to Week 16

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