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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

NCT02547935 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2019-08-21

Study results available
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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)

Conditions

  • Type 2 Diabetes Mellitus, CKD and Albuminuria

Interventions

DRUG

Dapagliflozin 10 mg

Tablets administered orally once daily for 24 weeks.

DRUG

Saxagliptin 2.5 mg

Tablets administered orally once daily for 24 weeks.

DRUG

Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

Tablets administered orally once daily for 24 weeks.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-21
Primary Completion
2018-05-18
Completion
2018-05-18

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • Mexico
  • South Africa
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02547935 on ClinicalTrials.gov