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NCT02413398 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 321
- Enrollment target
NCT02413398: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02413398 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 321 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02413398, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 321 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.
Primary Outcome
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
Interventions
- DRUG Dapagliflozin 10 mg
- DRUG Matching Placebo for Dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2015-06-15 |
| Est. Completion | 2017-11-07 |
| Phase | Phase 3 |
What the finished NCT02413398 record still lists
NCT02413398 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Dapagliflozin 10 mg is the first listed.
NCT02413398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02413398 about?
NCT02413398 is a clinical study titled "A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes". The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regi...
What is the current status of trial NCT02413398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 321 participants. The study started on 2015-06-15. Estimated completion is 2017-11-07.
What interventions are being tested in trial NCT02413398?
The interventions under investigation include: Dapagliflozin 10 mg (DRUG), Matching Placebo for Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT02413398?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02413398's enrollment target sits among peer trials
321 1081st of 2000 higher than 919 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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