Type 2 Diabetes Mellitus Clinical Trial
— PROMPTOfficial title:
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
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.
| Status | Completed |
| Enrollment | 286 |
| Est. completion date | December 2010 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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% Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Brugge | |
| Belgium | Research Site | Brussels (woluwe-st-lambert) | |
| Belgium | Research Site | Halen | |
| Belgium | Research Site | Lommel | |
| Belgium | Research Site | Moerkerke | |
| Belgium | Research Site | Oostham | |
| Belgium | Research Site | Sint-gillis-waas | |
| Belgium | Research Site | Tielt | |
| Belgium | Research Site | Zoersel | |
| France | Research Site | Chatellerault | |
| France | Research Site | Corbeil Essonnes | |
| France | Research Site | La Rochelle | |
| France | Research Site | La Seyne Sur Mer | |
| France | Research Site | Paris | |
| France | Research Site | Seysses | |
| France | Research Site | Tierce | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Ludwigshafen | |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | Rhaunen | |
| Germany | Research Site | Schmiedeberg | |
| Germany | Research Site | Wahlstedt | |
| Italy | Research Site | Bergamo | BG |
| Italy | Research Site | Forli | FC |
| Italy | Research Site | Milano | MI |
| Italy | Research Site | Padova | PD |
| Italy | Research Site | Pordenone | PN |
| Italy | Research Site | Roma | |
| Italy | Research Site | Siena | SI |
| Spain | Research Site | A Coruna | Galicia |
| Spain | Research Site | Alicante | Comunidad Valenciana |
| Spain | Research Site | Barcelona | Cataluna |
| Spain | Research Site | Madrid | Comunidad de Madrid |
| Spain | Research Site | Oviedo | Asturias |
| Spain | Research Site | San Sebastian de Los Reyes | Comunidad de Madrid |
| Spain | Research Site | Sevilla | Andalucia |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Bursa | |
| Turkey | Research Site | Kirikkale | |
| United Kingdom | Research Site | Ashford | |
| United Kingdom | Research Site | Atherstone | Warwickshire |
| United Kingdom | Research Site | Bath | |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Leamington Spa | Warwks |
| United Kingdom | Research Site | Peterborough | |
| United Kingdom | Research Site | Reading | Berks |
| United Kingdom | Research Site | Warminster | Wiltshire |
| United Kingdom | Research Site | Westbury | Wiltshire |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Bristol-Myers Squibb |
Belgium, France, Germany, Italy, Spain, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Absolute Change From Baseline in HbA1c at Week 24 | Baseline and 24 weeks | No | |
| Secondary | Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0% | Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent | 24 Weeks | No |
| Secondary | Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5% | Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent | 24 Weeks | No |
| Secondary | Change From Baseline to Week 24 in Fasting Plasma Glucose | Baseline and 24 weeks | No | |
| Secondary | Change From Baseline to Week 24 in Fasting Insulin | Baseline and 24 weeks | No | |
| Secondary | Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta | Baseline and 24 weeks | No |
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