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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00256867




Registration number
NCT00256867
Ethics application status
Date submitted
18/11/2005
Date registered
22/11/2005

Titles & IDs
Public title
A Study In Patients With Type 2 Diabetes Mellitus
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
Secondary ID [1] 0 0
AVS101946
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
Timepoint [1] 0 0
Baseline (Week 0) and Week 6
Secondary outcome [1] 0 0
Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy
Timepoint [1] 0 0
Baseline (Week 0) and Week 16
Secondary outcome [2] 0 0
Median Percent Change From Baseline to Week 6 in LDL-c
Timepoint [2] 0 0
Baseline (Week 0) and Week 6
Secondary outcome [3] 0 0
Mean Change From Baseline to Week 16 in HbA1c
Timepoint [3] 0 0
Baseline (Week 0) and Week 16
Secondary outcome [4] 0 0
Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)
Timepoint [4] 0 0
Baseline (Week 0) and Week 16
Secondary outcome [5] 0 0
Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6
Timepoint [5] 0 0
Week 6
Secondary outcome [6] 0 0
Number of Participants With HbA1c < 7.0% or Reduction of HbA1c = 0.7% at Week 16
Timepoint [6] 0 0
Up to Week 16
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate
Timepoint [8] 0 0
Up to Week 16
Secondary outcome [9] 0 0
On-Therapy Change From Baseline in Body Weight
Timepoint [9] 0 0
Up to Week 16
Secondary outcome [10] 0 0
Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine
Timepoint [10] 0 0
Up to Week 16
Secondary outcome [11] 0 0
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Timepoint [11] 0 0
Up to Week 16
Secondary outcome [12] 0 0
Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline
Timepoint [12] 0 0
Up to Week 16

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2006
Sample size
Target
Accrual to date
Final
369
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [2] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Keswick
Recruitment hospital [5] 0 0
GSK Investigational Site - Port Lincoln
Recruitment hospital [6] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [7] 0 0
GSK Investigational Site - Heidelberg West
Recruitment hospital [8] 0 0
GSK Investigational Site - Ringwood East
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5035 - Keswick
Recruitment postcode(s) [5] 0 0
5606 - Port Lincoln
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [8] 0 0
3135 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
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New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
New Brunswick
Country [27] 0 0
Canada
State/province [27] 0 0
Newfoundland and Labrador
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
Country [32] 0 0
Mexico
State/province [32] 0 0
Jalisco
Country [33] 0 0
Mexico
State/province [33] 0 0
Morelos
Country [34] 0 0
Mexico
State/province [34] 0 0
Nuevo León
Country [35] 0 0
Mexico
State/province [35] 0 0
Mexico
Country [36] 0 0
Philippines
State/province [36] 0 0
Manila
Country [37] 0 0
Philippines
State/province [37] 0 0
Quezon City
Country [38] 0 0
Puerto Rico
State/province [38] 0 0
Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00256867