Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-10

Study Completion Date

2019-07-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sequence A

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

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

Empagliflozin will be taken once daily

Placebo (matching empagliflozin)

Intervention Type DRUG

Placebo will be taken once daily

ramipril

Intervention Type DRUG

Ramipril will be taken once or twice daily

Sequence B

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

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

Empagliflozin will be taken once daily

Placebo (matching empagliflozin)

Intervention Type DRUG

Placebo will be taken once daily

ramipril

Intervention Type DRUG

Ramipril will be taken once or twice daily

Interventions

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Empagliflozin

Empagliflozin will be taken once daily

Intervention Type DRUG

Placebo (matching empagliflozin)

Placebo will be taken once daily

Intervention Type DRUG

ramipril

Ramipril will be taken once or twice daily

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No