CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 650 enrolled
Drug / intervention
Saxagliptin, Onglyza +3 moredrug
Likely dose
Saxagliptin, Onglyza 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/NCT02551874
NCT02551874Phase 3Completed
CompareCT.gov

A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy

AstraZeneca·interventional·Posted Sep 16, 2015·Updated Dec 11, 2018

In Brief

A Phase 3 clinical trial evaluating Saxagliptin, Onglyza, Dapagliflozin, Farxiga, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 650 participants across 40 sites in 10 countries.

Detailed Summary

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCzechia, Denmark, Hungary, Mexico, Poland, Romania, South Africa, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 16, 2015
Enrollment StartOct 20, 2015
Primary CompletionMay 8, 2017
Study CompletionNov 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago

Interventions

Saxagliptin, Onglyzadrug

Tablets, Oral, 5mg , Once daily, 24 weeks

Dapagliflozin, Farxigadrug

Tablets, Oral, 10mg , Once daily, 24 weeks

Glargine insulindrug

100 Units/ml solution for injection in a prefilled SoloStar pen

Metformindrug

Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks