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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00121641




Registration number
NCT00121641
Ethics application status
Date submitted
15/07/2005
Date registered
21/07/2005
Date last updated
3/04/2015

Titles & IDs
Public title
Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Secondary ID [1] 0 0
CV181-011
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
Treatment: Drugs - Saxagliptin
Treatment: Drugs - Saxagliptin
Treatment: Drugs - Placebo matching Saxagliptin
Treatment: Drugs - Metformin
Treatment: Drugs - Placebo matching Metformin
Treatment: Drugs - Saxagliptin
Treatment: Drugs - Metformin

Experimental: Saxagliptin 2.5 mg (A) - Metformin 500-2000 mg (as needed for rescue)

Experimental: Saxagliptin 5 mg (B) - Metformin 500-2000 mg (as needed for rescue)

Experimental: Saxagliptin 10 mg (C) - Metformin 500-2000 mg (as needed for rescue)

Placebo comparator: Placebo (D) - Metformin 500-2000 mg (as needed for rescue)

Experimental: Open-Label Treatment Cohort (Direct Enrollees) (E) - Saxagliptin 10 mg

Metformin 500-2000 mg (as needed for rescue)


Treatment: Drugs: Saxagliptin
Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\])

Treatment: Drugs: Saxagliptin
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)

Treatment: Drugs: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)

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

Treatment: Drugs: Metformin
Tablets, Oral, 500 mg, daily (42 months LT)

Treatment: Drugs: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)

Treatment: Drugs: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label

Treatment: Drugs: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemoglobin A1c (A1C) Changes From Baseline at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
A1C Changes From Baseline at Week 24 - Open Label Cohort
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)
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
Secondary outcome [4] 0 0
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort
Timepoint [6] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
* Type 2 diabetes mellitus
* Drug naive
* Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
* Fasting C-peptide >= 1 ng/mL
* Body mass index <= 40 kg/m2
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 Women of Child Bearing Potential

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
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
1035
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
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United States of America
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Alabama
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Arizona
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Kentucky
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Ontario
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Hualien
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise
Trial website
https://clinicaltrials.gov/study/NCT00121641
Trial related presentations / publications
Rosenstock J, Aguilar-Salinas C, Klein E, Nepal S, List J, Chen R; CV181-011 Study Investigators. Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes. Curr Med Res Opin. 2009 Oct;25(10):2401-11. doi: 10.1185/03007990903178735.
Esu E, Berens-Riha N, Pritsch M, Nwachuku N, Loescher T, Meremikwu M. Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria. Malar J. 2018 Jul 6;17(1):251. doi: 10.1186/s12936-018-2394-2.
Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
Bonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.
Rosenstock J, Gross JL, Aguilar-Salinas C, Hissa M, Berglind N, Ravichandran S, Fleming D. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes. Diabet Med. 2013 Dec;30(12):1472-6. doi: 10.1111/dme.12267. Epub 2013 Jul 19.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00121641