Clinical trial NCT00256867: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes Type II
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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:
measure: Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy
timeFrame: Baseline (Week 0) and Week 16
measure: Median Percent Change From Baseline to Week 6 in LDL-c
timeFrame: Baseline (Week 0) and Week 6
measure: Mean Change From Baseline to Week 16 in HbA1c
timeFrame: Baseline (Week 0) and Week 16
measure: Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (Week 0) and Week 16
measure: Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6
timeFrame: Week 6
measure: Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16
timeFrame: Up to Week 16
measure: 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
measure: On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate
timeFrame: Up to Week 16
measure: On-Therapy Change From Baseline in Body Weight
timeFrame: Up to Week 16
measure: Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine
timeFrame: Up to Week 16
measure: Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
timeFrame: Up to Week 16
measure: Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Cloud
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Melrose Park
country: United States
facility: GSK Investigational Site
state: Illinois
city: Springfield
country: United States
facility: GSK Investigational Site
state: Illinois
city: Avon
country: United States
facility: GSK Investigational Site
state: Indiana
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Waltham
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Saint Peters
country: United States
facility: GSK Investigational Site
state: Missouri
city: Billings
country: United States
facility: GSK Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Jamaica
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Bend
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Tualatin
country: United States
facility: GSK Investigational Site
state: Oregon
city: Beaver
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Fleetwood
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Clinton
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Bryan
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Georgetown
country: United States
facility: GSK Investigational Site
state: Texas
city: Midland
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Manassas
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Vancouver
country: United States
facility: GSK Investigational Site
state: Washington
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Keswick
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Port Lincoln
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg West
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Mount Pearl
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Woodstock
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Bonaventure
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Gatineau
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Granby
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Plessisville
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Marc Des Carrieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Carolina
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: