Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
CV181-011
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Hemoglobin A1c (A1C) Changes From Baseline at Week 24
Query!
Assessment method [1]
0
0
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%.
Query!
Timepoint [1]
0
0
Baseline, Week 24
Query!
Primary outcome [2]
0
0
A1C Changes From Baseline at Week 24 - Open Label Cohort
Query!
Assessment method [2]
0
0
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%.
Query!
Timepoint [2]
0
0
Baseline, Week 24
Query!
Secondary outcome [1]
0
0
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline, Week 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Week 24
Query!
Secondary outcome [3]
0
0
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline, Week 24
Query!
Secondary outcome [4]
0
0
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Baseline, Week 24
Query!
Secondary outcome [5]
0
0
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Week 24
Query!
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
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Baseline, Week 24
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
77
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1035
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Sydney
Query!
Recruitment hospital [2]
0
0
Local Institution - Woollongong
Query!
Recruitment hospital [3]
0
0
Local Institution - Brisbane
Query!
Recruitment hospital [4]
0
0
Local Institution - Kippa Ring
Query!
Recruitment hospital [5]
0
0
Local Institution - Meadowbrook
Query!
Recruitment hospital [6]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [7]
0
0
Local Institution - Woodville South
Query!
Recruitment hospital [8]
0
0
Local Institution - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Sydney
Query!
Recruitment postcode(s) [2]
0
0
- Woollongong
Query!
Recruitment postcode(s) [3]
0
0
- Brisbane
Query!
Recruitment postcode(s) [4]
0
0
- Kippa Ring
Query!
Recruitment postcode(s) [5]
0
0
- Meadowbrook
Query!
Recruitment postcode(s) [6]
0
0
- Adelaide
Query!
Recruitment postcode(s) [7]
0
0
- Woodville South
Query!
Recruitment postcode(s) [8]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Mississippi
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Montana
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nebraska
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Utah
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Alberta
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
British Columbia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Manitoba
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
New Brunswick
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Newfoundland and Labrador
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Ontario
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Prince Edward Island
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Quebec
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Saskatchewan
Query!
Country [41]
0
0
Mexico
Query!
State/province [41]
0
0
Distrito Federal
Query!
Country [42]
0
0
Mexico
Query!
State/province [42]
0
0
Jalisco
Query!
Country [43]
0
0
Mexico
Query!
State/province [43]
0
0
Nuevo Leon
Query!
Country [44]
0
0
Mexico
Query!
State/province [44]
0
0
Sonora
Query!
Country [45]
0
0
Mexico
Query!
State/province [45]
0
0
Aguascalientes
Query!
Country [46]
0
0
Mexico
Query!
State/province [46]
0
0
Durango
Query!
Country [47]
0
0
Puerto Rico
Query!
State/province [47]
0
0
Carolina
Query!
Country [48]
0
0
Puerto Rico
Query!
State/province [48]
0
0
Guaynabo
Query!
Country [49]
0
0
Puerto Rico
Query!
State/province [49]
0
0
Ponce
Query!
Country [50]
0
0
Puerto Rico
Query!
State/province [50]
0
0
Rio Piedras
Query!
Country [51]
0
0
Puerto Rico
Query!
State/province [51]
0
0
San Juan
Query!
Country [52]
0
0
Taiwan
Query!
State/province [52]
0
0
Hualien
Query!
Country [53]
0
0
Taiwan
Query!
State/province [53]
0
0
Taichung
Query!
Country [54]
0
0
Taiwan
Query!
State/province [54]
0
0
Taipei
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/study/NCT00121641
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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/NCT00121641
Download to PDF