Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1; Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Placebo (matching empagliflozin); Drug: Empagliflozin; Drug: ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT02632747

1245.100

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Sequence A

Experimental group

Description:

Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.

Treatment:

Drug: Empagliflozin

Drug: ramipril

Drug: Placebo (matching empagliflozin)

Sequence B

Experimental group

Description:

Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.

Treatment:

Drug: Empagliflozin

Drug: ramipril

Drug: Placebo (matching empagliflozin)