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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00121667




Registration number
NCT00121667
Ethics application status
Date submitted
18/07/2005
Date registered
21/07/2005
Date last updated
29/04/2015

Titles & IDs
Public title
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
Scientific title
"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"
Secondary ID [1] 0 0
CV181-014
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 - Saxagliptin + Metformin
Treatment: Drugs - Saxagliptin + Metformin
Treatment: Drugs - Saxagliptin + Metformin
Treatment: Drugs - Placebo + Metformin
Treatment: Drugs - Pioglitazone

Experimental: Saxagliptin + Metformin (A) - Pioglitazone 15-45 mg (as needed for rescue)

Experimental: Saxagliptin + Metformin (B) - Pioglitazone 15-45 mg (as needed for rescue)

Experimental: Saxagliptin + Metformin (C) - Pioglitazone 15-45 mg (as needed for rescue)

Placebo comparator: Placebo+ Metformin (D) - Pioglitazone 15-45 mg (as needed for rescue)


Treatment: Drugs: Saxagliptin + Metformin
Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Treatment: Drugs: Saxagliptin + Metformin
Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Treatment: Drugs: Saxagliptin + Metformin
Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)

Treatment: Drugs: Placebo + Metformin
Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)

Treatment: Drugs: Pioglitazone
Tablets, Oral, 15 - 45 mg (as needed for rescue)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
Timepoint [3] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
* Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
* HbA1c >= 7.0% and <= 10.0 %
* Body mass index <= 40 kg/m2
* Fasting C-peptide >= 1 ng/dL
Minimum age
18 Years
Maximum age
77 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Symptomatic poorly controlled diabetes
* Recent cardiac or cerebrovascular event
* Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females

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
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
1462
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Local Institution - Sydney
Recruitment hospital [2] 0 0
Local Institution - Woollongong
Recruitment hospital [3] 0 0
Local Institution - Brisbane
Recruitment hospital [4] 0 0
Local Institution - Kippa Ring
Recruitment hospital [5] 0 0
Local Institution - Meadowbrook
Recruitment hospital [6] 0 0
Local Institution - Adelaide
Recruitment hospital [7] 0 0
Local Institution - Woodville South
Recruitment hospital [8] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Woollongong
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Kippa Ring
Recruitment postcode(s) [5] 0 0
- Meadowbrook
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Woodville South
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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Arkansas
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California
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Missouri
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Nebraska
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Washington
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Cordoba
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Brazil
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Ceara
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Brazil
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Para
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Brazil
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Brazil
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Sao Paulo
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Manitoba
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New Brunswick
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Ontario
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Hualien
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Taichung
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No information has been provided regarding IPD availability


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/NCT00121667