Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
PROMPT
A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin
1 other identifier
interventional
286
7 countries
51
Brief Summary
The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Oct 2009
Shorter than P25 for phase_4 type-2-diabetes-mellitus
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 31, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
January 5, 2012
CompletedJanuary 19, 2012
January 1, 2012
October 31, 2009
November 30, 2011
January 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in HbA1c at Week 24
Baseline and 24 weeks
Secondary Outcomes (5)
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
24 Weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
24 Weeks
Change From Baseline to Week 24 in Fasting Plasma Glucose
Baseline and 24 weeks
Change From Baseline to Week 24 in Fasting Insulin
Baseline and 24 weeks
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
Baseline and 24 weeks
Study Arms (2)
1
EXPERIMENTALSaxagliptin 5 mg
2
ACTIVE COMPARATORMetformin 500 -1000 mg
Interventions
Eligibility Criteria
You may qualify if:
- Provision of signed informed consent
- Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
- HbA1c ≥7.0% and ≤10.0%
You may not qualify if:
- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
- Renal impairment as defined by a creatinine clearance \<60 mL/min/1.73 m2
- Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (51)
Research Site
Brussels (woluwe-st-lambert), Belgium, Belgium
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Halen, Belgium, Belgium
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Lommel, Belgium, Belgium
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Oostham, Belgium, Belgium
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Sint-Gillis-Waas, Belgium, Belgium
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Zoersel, Belgium, Belgium
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Bruges, Belgium
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Moerkerke, Belgium
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Tielt, Belgium
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Châtellerault, France
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Corbeil-Essonnes, France
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La Rochelle, France
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La Seyne-sur-Mer, France
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Paris, France
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Seysses, France
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Tiercé, France
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Berlin, Germany
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Freiburg im Breisgau, Germany
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Leipzig, Germany
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Ludwigshafen, Germany
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Mannheim, Germany
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Rhaunen, Germany
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Schmiedeberg, Germany
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Wahlstedt, Germany
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Bergamo, BG, Italy
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Forlì, FC, Italy
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Milan, MI, Italy
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Padua, PD, Italy
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Pordenone, PN, Italy
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Siena, SI, Italy
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Roma, Italy
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
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San Sebastián de los Reyes, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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Alicante, Valencia, Spain
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Ankara, Turkey, Turkey (Türkiye)
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Bursa, Turkey, Turkey (Türkiye)
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Kırıkkale, Turkey, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Reading, Berks, United Kingdom
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Atherstone, Warwickshire, United Kingdom
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Royal Leamington Spa, Warwks, United Kingdom
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Warminster, Wiltshire, United Kingdom
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Westbury, Wiltshire, United Kingdom
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Ashford, United Kingdom
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Bath, United Kingdom
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Coventry, United Kingdom
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Peterborough, United Kingdom
Related Publications (1)
Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.
PMID: 23020253DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2009
First Posted
November 3, 2009
Study Start
October 1, 2009
Study Completion
December 1, 2010
Last Updated
January 19, 2012
Results First Posted
January 5, 2012
Record last verified: 2012-01