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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
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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"
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Secondary ID [1]
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CV181-014
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24
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Assessment method [1]
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Mean change from baseline is adjusted for baseline value.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [1]
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Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
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Assessment method [1]
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Mean change from baseline is adjusted for baseline value.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
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Assessment method [2]
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
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Assessment method [3]
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Mean change from baseline is adjusted for baseline value.
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Timepoint [3]
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Baseline, Week 24
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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
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Minimum age
18
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Maximum age
77
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
1/02/2010
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Sample size
Target
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Accrual to date
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Final
1462
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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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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- Adelaide
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- Woodville South
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- Perth
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone
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Trial website
https://clinicaltrials.gov/study/NCT00121667
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Trial related presentations / publications
DeFronzo RA, Hissa MN, Garber AJ, Luiz Gross J, Yuyan Duan R, Ravichandran S, Chen RS; Saxagliptin 014 Study Group. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009 Sep;32(9):1649-55. doi: 10.2337/dc08-1984. Epub 2009 May 28. Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26. 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. Karyekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24. Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.
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Public notes
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Contacts
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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
Download to PDF