24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared with Acarbose when in Combination with Metformin in Patients with T2D Inadequately Controlled with Metformin Monotherapy - SMART
Study identifier:D1680L00018
ClinicalTrials.gov identifier:NCT02243176
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 4
Healthy volunteers
No
Study drug
Saxagliptin, Acarbose
Sex
All
Actual Enrollment
689
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Sept 2014
Primary Completion Date: 01 Sept 2015
Study Completion Date: 01 Sept 2015
Study design
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Saxagliptin The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm. | Drug: Saxagliptin The dose of saxaglitpin will be 5mg oral qd. Other Name: Onglyza |
| Active Comparator: Acarbose Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm. | Drug: Acarbose Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. Other Name: Glucobay |
