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NCT02613897 · ClinicalTrials.gov registry record · NA
ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study
A NA study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT02613897: Completed NA study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT02613897 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613897, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a 16-week, single center, randomized, double-blind, active-controlled, parallel-group, Phase 3b efficacy and safety study of simultaneous administration of saxagliptin 5 mg plus dapagliflozin 10 mg once daily (QD) compared with dapagliflozin plus placebo for saxagliptin, and placebo for saxagliptin plus placebo for dapagliflozin in patients with Type 2 diabetes who have inadequate glycemic control on metformin or metformin/sulfonylurea.
Primary Outcome
All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP.
Interventions
- DRUG Placebo
- DRUG Dapagliflozin
- DRUG Saxagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-06-30 |
| Phase | NA |
What the finished NCT02613897 record still lists
NCT02613897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02613897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02613897 about?
NCT02613897 is a clinical study titled "ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study". This is a 16-week, single center, randomized, double-blind, active-controlled, parallel-group, Phase 3b efficacy and safety study of simultaneous administration of saxagliptin 5 mg plus dapagliflozin 10 mg once daily (QD) compared with dapagliflozin plus placebo for saxagliptin, and placebo for saxa...
What is the current status of trial NCT02613897?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2016-01. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT02613897?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin (DRUG), Saxagliptin (DRUG).
Who is sponsoring clinical trial NCT02613897?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02613897's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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