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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

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

Evaluate Efficacy and Safety of Saxagliptin  in combination with Metformin in Adult Patients with Type 2 Diabetes

Research Site

A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy

Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value.  *Adjusted for baseline HbA1c.

Age Continuous

Gender, Male/Female

Baseline

Week 24

adjusted baseline HbA1c

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.

Absolute change from baseline to week 24  in glycosylated haemoglobin A1c (HbA1c)

Adjusted Change from Baseline

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value.  *Adjusted for baseline FPG.

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement

Absolute change from baseline to week 24 in fasting plasma glucose (FPG) mmol/L

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value.  *Adjusted for baseline FPG.

Absolute change from baseline to week 24 in fasting plasma glucose (FPG) mg/dL

Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value.  *Adjusted for baseline PPG AUC.

MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24.  Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.

Change from baseline in the area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during a mixed meal tolerance test (MMTT) in a subgroup

Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value.  *Adjusted for baseline PPG AUC.

Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.

Arms	Assigned Interventions
Experimental: 1 Metformin + Saxagliptin	Drug: Saxagliptin Oral tablet, once daily for 24 weeks Other Name: Onglyza Drug: Metformin oral tablet, once daily for 24 weeks Other Name: Glucophage
Placebo Comparator: 2 Metformin + Placebo	Drug: Placebo oral tablet, once daily for 24 weeks Drug: Metformin oral tablet, once daily for 24 weeks Other Name: Glucophage

Evaluate Efficacy and Safety of Saxagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes

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=283&filename=CSR-D1680C00006.pdf

CSR-D1680C00006.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator