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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 sulphonylurea in addition with metformin.

52-week add-on to metformin comparison of saxagliptin and sulphonylurea, with a 52-week extension period

Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)

Research Site

A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III study with a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination with Metformin compared with Sulphonylurea in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone.

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.

Age Continuous

Gender, Male/Female

Baseline

Week 52

Adjusted Change from Baseline to Week 52

Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations

Hemoglobin A1c (HbA1c) change from baseline to Week 52

Proportion of participants reporting at least one episode of any hypoglycaemic event  for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)

Proportion of participants reporting at least one episode of any hypoglycaemic event over 52 weeks

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.

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

Body weight change from baseline to Week 52

Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Mean slope of the regressions of change from Week 24 to Week 52 in HbA1c

Week 104

Adjusted Change from Baseline to Week 104

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.

Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin

Hemoglobin A1c (HbA1c) change from baseline to Week 104

Proportion of participants reporting at least one episode of any hypoglycaemic event  for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)

Proportion of participants reporting at least one episode of any hypoglycaemic event over 104 weeks

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.

Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin

Body weight change from baseline to Week 104

Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Mean slope of the regressions of change from Week 24 to Week 104 in HbA1c

Overall Study

891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated.

Arms	Assigned Interventions
Experimental: Saxagliptin	Drug: Metformin open-label metformin Drug: Saxagliptin Saxagliptin 5 mg tablets Other Name: Onglyza
Experimental: Glipizide	Drug: Metformin open-label metformin Drug: Sulphonylurea Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)

52-week add-on to metformin comparison of saxagliptin and sulphonylurea, with a 52-week extension period

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=1815&filename=CSR-D1680C00001.pdf

CSR-D1680C00001.pdf

D1680C00001 Clinical Study Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator