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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C =7.0% and =10.0%.
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
A1C Changes From Baseline at Week 24 - Open Label Cohort - To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C =7.0% and =10.0%.
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
Gender
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
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,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
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- Sydney
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- Woollongong
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- Brisbane
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- Kippa Ring
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- 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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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/show/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-naïve patients with type 2 diabetes. Curr Med Res Opin. 2009 Oct;25(10):2401-11. doi: 10.1185/03007990903178735.
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
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Contact person for scientific queries

Summary results
Other publications