Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

• Status: Completed
• Trial end date: 2019-07-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Empagliflozin; Ramipril

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