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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 assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

18-week add-on to metformin comparison of Saxagliptin and Sitagliptin in Adult Patients with Type 2 Diabetes (T2D)

Research Site

18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with T2D Who Have Inadequate Glycaemic Control on Metformin Alone

Adjusted mean change from baseline in HbA1c  achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol 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

Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations.

Hemoglobin A1c (HbA1c) change from baseline to Week 18

Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)

Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement.

Proportion of patients achieving therapeutic glycaemic response defined as HbA1c <= 6.5% at Week 18

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

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.

Fasting Plasma Glucose change from baseline to week 18 (mg/dL)

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

Arms	Assigned Interventions
Experimental: 1 saxagliptin add-on to metformin	Drug: saxagliptin tablet, per oral, once daily Other Name: Onglyza
Active Comparator: 2 sitagliptin add-on to metformin	Drug: sitagliptin capsule, per oral, once daily Other Name: Januvia

18-week add-on to metformin comparison of Saxagliptin and Sitagliptin in Adult Patients with Type 2 Diabetes (T2D)

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=281&filename=CSR-D1680C00002.pdf

CSR-D1680C00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator