Clinical trial NCT02632747: Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
Official title: A Double-blind, Placebo Controlled, Cross-over Renal Mechanistic Trial to Assess the Effect of Adding Empagliflozin Versus Placebo on Renal Hyperfiltration on a Background of the Angiotensin Converting Enzyme Inhibitor (ACEi) Ramipril: BETWEEN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-12-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* Signed and dated written informed consent.
* Male or female patients diagnosed with type 1 diabetes (T1D) at least 6 months prior to informed consent or type 2 diabetes (T2D) or non-diabetic obese patients.
* T1D patients must use and be willing of and be willing to continue throughout the duration of the trial either:
* multiple daily injections of insulin OR
* continuous sub-cutaneous insulin infusion of any insulin type, with at least 3 months experience
* For patients with T1D or T2D,HbA1c of 6.5 - 11%
* Age at least 18 years of age
* Body mass index of \>=18.5 kg/m\^2
* Estimated glomerular filtration rate greater than or equal to 60 ml/min/1.73m2
* Blood pressure greater than 90 /60 mmHg and less than or equal to 140 / 90 mmHg
* Use of a highly effective method of contraception.
* Further inclusion criteria apply

Exclusion criteria:

* For patients with T1D, treatment with an antihyperglycaemic agent within 3 months prior to visit 1
* occurrence of severe hypoglycaemia within 3 months prior to visit 1
* hypoglycaemic unawareness within 3 months prior to visit 1
* occurrence of diabetic ketoacidosis within 3 months of visit 1 and until visit 3 Further exclusion criteria apply

Primary outcomes:
measure: Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril.
timeFrame: At week 4 and at week 12
Secondary outcomes:
measure: 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
timeFrame: At week 4 and at week 12.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Lytvyn Y, Kimura K, Peter N, Lai V, Tse J, Cham L, Perkins BA, Soleymanlou N, Cherney DZI. Renal and Vascular Effects of Combined SGLT2 and Angiotensin-Converting Enzyme Inhibition. Circulation. 2022 Aug 9;146(6):450-462. doi: 10.1161/CIRCULATIONAHA.122.059150. Epub 2022 Jul 11.