EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

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.

Efficacy and tolerability of saxagliptin add-on compared to uptitration of  metformin in patients with Type 2 diabetes

500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy

Research Site

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

Age Continuous

Gender, Male/Female

The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%

Absolute change from baseline in HbA1c at Week 24

Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent

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 or equal to 6.5 percent

Proportion of patients achieving a therapeutic response at Week 24 defined as HbA1c<=6.5%

Change from baseline to Week 24 in fasting plasma glucose

Change from baseline to Week 24 in fasting insulin

Change from baseline to Week 24 in beta-cell function as measured by Homeostasis Model Assessment-2-beta

Overall Study

Screening, enrollment (2 weeks) and lead-in period (4 weeks). Main reason for not being randomised was due to renal function not meeting inclusion criteria. (Samples taken and analysed after enrollment into the study but prior to randomisation).

Arms	Assigned Interventions
Experimental: 1 Saxagliptin 5 mg	Drug: Saxagliptin 5 mg, oral tablet, once daily Other Name: Onglyza
Active Comparator: 2 Metformin 500 -1000 mg	Drug: Metformin 500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy Other Name: Metformin

Efficacy and tolerability of saxagliptin add-on compared to uptitration of metformin in patients with Type 2 diabetes - PROMPT

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=286&filename=CSR-D1680L00003.pdf

CSR-D1680L00003.pdf

Trial Results Summaries

Contacts

Contact