Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01006590
• Date of registration: 31/10/2009
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes PROMPT
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 286
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01006590
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Belgium, France, Germany, Italy, Spain, Turkey, United Kingdom

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Metformin

Drug: Saxagliptin

Primary Outcome(s)

Absolute Change From Baseline in HbA1c at Week 24 [Time Frame: Baseline and 24 weeks]

Secondary Outcome(s)

Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta [Time Frame: Baseline and 24 weeks]

Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0% [Time Frame: 24 Weeks]

Change From Baseline to Week 24 in Fasting Insulin [Time Frame: Baseline and 24 weeks]

Change From Baseline to Week 24 in Fasting Plasma Glucose [Time Frame: Baseline and 24 weeks]

Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5% [Time Frame: 24 Weeks]

Secondary ID(s)

D1680L00003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb

Results

• Results available: Yes
• Date Posted: 05/01/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01006590