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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00067951




Registration number
NCT00067951
Ethics application status
Date submitted
3/09/2003
Date registered
5/09/2003
Date last updated
21/03/2018

Titles & IDs
Public title
A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
Scientific title
An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
712753/004
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
Treatment: Drugs - rosiglitazone/metformin

Treatment: Drugs: rosiglitazone/metformin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Laboratory result for HbA1c >11% or FPG >270mg/dL

- Clinical diagnosis of Type II diabetes

- Prior treatment with diet and/or exercise alone, or less than 15 days of prior
treatment with an oral anti-diabetic medication or insulin.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
17/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2004
Sample size
Target
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [3] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [4] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [5] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [6] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [7] 0 0
GSK Investigational Site - Caulfield
Recruitment hospital [8] 0 0
GSK Investigational Site - Fremantle
Recruitment hospital [9] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3162 - Caulfield
Recruitment postcode(s) [8] 0 0
6959 - Fremantle
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
Country [15] 0 0
United States of America
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Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
New Brunswick
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Canada
State/province [25] 0 0
Saskatchewan
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Pusan
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Uijeongbu,
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Christchurch
Country [31] 0 0
New Zealand
State/province [31] 0 0
Rotorua
Country [32] 0 0
New Zealand
State/province [32] 0 0
Wellington

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this research study is to determine if a new investigational diabetes drug is
safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c
or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test
or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood
over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood
after an 8 hour fast.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00067951
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00067951