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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.

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Official Title

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.

An 18  Week Efficacy and Safety Study of Saxagliptin  and Metformin XR Combination in Subjects with Type 2 Diabetes

Research Site

18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo with Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control After Diet/Exercise and a stable dose of Metformin XR 1500mg

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.

Age Continuous

Gender, Male/Female

Baseline

Week 18

Adjusted Change from Baseline to Week 18

Change in HbA1c level from baseline to Week 18 (LOCF)

Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.

Change in 2-hour PPG following mixed meal tolerance test (MMTT) from baseline to Week 18 (LOCF)

Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.

Change in FPG from baseline to Week 18 (LOCF)

Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set)

Percent of subjects reaching goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)

Overall Study

Of the 393 subjects who entered the lead-in period, 111 subjects did not enter the randomized, double-blind treatment period. Thus, a total of 282 subjects were randomized and treated.

Arms	Assigned Interventions
Experimental: 1 Saxagliptin	Drug: Saxagliptin 5mg oral tablet once daily Other Name: Onglyza Drug: Metformin XR 750mg, 2 tablets once daily
Active Comparator: 2 Metformin Extended Release	Drug: Metformin XR 500mg oral tablet once daily Drug: Metformin XR 750mg, 2 tablets once daily

An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects with Type 2 Diabetes - SCORE

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=287&filename=CSR-D1680L00005.pdf

CSR-D1680L00005.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator