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NCT02547935 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
459
Enrollment target

NCT02547935: Completed Phase 2 study, sponsored by AstraZeneca.

NCT02547935 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 459 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (245% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02547935, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
459 participants
Enrollment target

Study Summary

The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)

Primary Outcome

HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model.

Interventions

  • DRUG Dapagliflozin 10 mg
  • DRUG Saxagliptin 2.5 mg
  • DRUG Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

Trial Details

FieldValue
Enrollment Target 459 participants
Start Date 2015-09-21
Est. Completion 2018-05-18
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT02547935 record still lists

NCT02547935 is an interventional study that assigns participants to a tested intervention. The registered 459 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (245% higher).

The record links to 0 conditions, and to 3 interventions - of which Dapagliflozin 10 mg is the first listed.

NCT02547935 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02547935 about?

NCT02547935 is a clinical study titled "A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD". The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 ...

What is the current status of trial NCT02547935?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 459 participants. The study started on 2015-09-21. Estimated completion is 2018-05-18.

What interventions are being tested in trial NCT02547935?

The interventions under investigation include: Dapagliflozin 10 mg (DRUG), Saxagliptin 2.5 mg (DRUG), Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg (DRUG).

Who is sponsoring clinical trial NCT02547935?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02547935's enrollment target sits among peer trials

459 84th of 2000 higher than 1,917 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02547935, the US trial registry maintained by the National Library of Medicine. NCT02547935 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.