CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 689 enrolled
Drug / intervention
Saxagliptin +1 moredrug
Likely dose
Saxagliptin 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02243176
NCT02243176Phase 4Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Sep 17, 2014·Updated Apr 14, 2017

In Brief

A Phase 4 clinical trial evaluating Saxagliptin and Acarbose for Type 2 Diabetes Mellitus. Completed, enrolled 689 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 17, 2014
Enrollment StartSep 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.8 years ago

Interventions

Saxagliptindrug

The dose of saxaglitpin will be 5mg oral qd.

Acarbosedrug

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.