ClinicalTrials.gov
ClinicalTrials.gov Menu

Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02632747
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Obesity Drug: Empagliflozin Drug: Placebo (matching empagliflozin) Drug: ramipril Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2016
Estimated Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence A
Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
Drug: Empagliflozin
Empagliflozin will be taken once daily

Drug: Placebo (matching empagliflozin)
Placebo will be taken once daily

Drug: ramipril
Ramipril will be taken once or twice daily

Experimental: Sequence B
Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.
Drug: Empagliflozin
Empagliflozin will be taken once daily

Drug: Placebo (matching empagliflozin)
Placebo will be taken once daily

Drug: ramipril
Ramipril will be taken once or twice daily




Primary Outcome Measures :
  1. Change in glomerular filtration rate (GFR) after treatment with either empagliflozin added to ramipril or placebo added to ramipril. [ Time Frame: At week 4 and 12 ]

Secondary Outcome Measures :
  1. Filtration status (GFR < 120 mL/min/1.73m^2; yes/no) after 4 weeks of treatment with either empagliflozin added to ramipril or placebo added to ramipril. [ Time Frame: At week 4 and 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632747


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02632747     History of Changes
Other Study ID Numbers: 1245.100
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Empagliflozin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents