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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/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
Sex
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
8/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/12/2004
Sample size
Target
Accrual to date
Final
453
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
State/province [2] 0 0
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
State/province [6] 0 0
Illinois
Country [7] 0 0
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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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
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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
State/province [28] 0 0
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
State/province [36] 0 0
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/ct2/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