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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00499707




Registration number
NCT00499707
Ethics application status
Date submitted
9/07/2007
Date registered
11/07/2007
Date last updated
21/03/2018

Titles & IDs
Public title
Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
Scientific title
A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
Secondary ID [1] 0 0
712753/007
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 maleate/metformin hydrochloride

Treatment: Drugs: rosiglitazone maleate/metformin hydrochloride
rosiglitazone maleate/metformin hydrochloride

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

Outcomes
Primary outcome [1] 0 0
Change from baseline in hemoglobin A1c (HbA1c) at week 32.
Timepoint [1] 0 0
at 32 week
Secondary outcome [1] 0 0
Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks
Timepoint [1] 0 0
at 32 weeksInvalid value

Eligibility
Key inclusion criteria
- 18 to 70 years of age

- Clinical diagnosis of type 2 diabetes

- HbA1c >7.5% to 11%

- FPG <270mg/dL (15mmol)

- Current treatment with diet and/or exercise alone, or no more than 15 days of an
anti-diabetic medication or insulin within 12 weeks of screening
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically significant renal or hepatic disease

- Presence of anemia

- Presence of unstable or severe angina, coronary insufficiency, or any congestive heart
failure requiring therapy

- Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on
anti-hypertensive treatment

- Chronic disease requiring intermittent or chronic treatment with corticosteroids

- Any female lactating, pregnant, or planning to become pregnant

- History of hepatocellular reaction, severe edema or a medically serious fluid related
event associated with any thiazolidinedione

- Presence of acute or chronic metabolic acidosis

- History of diabetic ketoacidosis

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?
The people receiving the treatment/s


The people analysing the results/data
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Louisiana
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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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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
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Brazil
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Pernambuco
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seoul
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Korea, Republic of
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Uijeongbu,
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Mexico
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Baja California Norte
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Mexico
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Durango
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Mexico
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Mexico, D.F.
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Rotorua
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New Zealand
State/province [39] 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 32 week study is to demonstrate that fixed-dose combination treatment
with rosiglitazone/metformin will safely and effectively control glycemia as first line oral
therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate
superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
Trial website
https://clinicaltrials.gov/show/NCT00499707
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
Other publications