Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Obesity
• Interventions: Drug: Empagliflozin; Drug: Placebo (matching empagliflozin); Drug: ramipril

• Registration Number: NCT02632747
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial with empagliflozin compared to placebo that is added to open-label ramipril.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Study Start: 2016-05-10
• Primary Completion: 2017-12-19
• Study Completion: 2019-07-02
• Status Verified: 2020-07
• Results First Submitted: 2020-07-02
• Results First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Results First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Empagliflozin	Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
Sequence A	ramipril	Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
Sequence A	Placebo (matching empagliflozin)	Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
Sequence B	Placebo (matching empagliflozin)	Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.
Sequence B	Empagliflozin	Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.
Sequence B	ramipril	Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.

Primary Outcome Measures

Name	Time	Method
Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril.	At week 4 and at week 12	Glomerular filtration rate (GFR) under euglycaemic conditions after 4 weeks of treatment with either empagliflozin added to ramipril or placebo added to ramipril.; The pre-specified statistical analysis was not conducted, because data are too sparse in the subgroup of hyperfilterers.

Secondary Outcome Measures

Name	Time	Method
Filtration Status (Glomerular Filtration Rate (GFR) < 120 mL/Min/1.73m², Yes/no) After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril	At week 4 and at week 12.	Filtration status (Glomerular Filtration Rate (GFR) \< 120 mL/min/1.73m²) after 4 weeks of treatment with either empagliflozin added to ramipril or placebo added to ramipril. Filtration status is defined as whether a patient has normal Filtration status (GFR \< mL/min/1.73m², "yes") or not (GFR ≥ mL/min/1.73m², "no").; The pre-specified statistical analysis was not conducted, because data are too sparse in the subgroup of hyperfilterers.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada