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OpenTrials
Completed

NCT Number: NCT02632747

Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

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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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin

Drug

Empagliflozin will be taken once daily

Placebo (matching empagliflozin)

Drug

Placebo will be taken once daily

Ramipril

Drug

Ramipril will be taken once or twice daily

Primary outcomes

  1. Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril.

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Dec 17, 2015
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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