Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

NCT02632747 | Completed Phase 2 Results

• 1 other identifier: 1245.100
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  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.

  At week 4 and at week 12

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

  At week 4 and at week 12.

Study Arms (2)

Sequence A

EXPERIMENTAL

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

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

Sequence B

EXPERIMENTAL

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

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

Interventions

Empagliflozin DRUG

Empagliflozin will be taken once daily

Sequence A; Sequence B

Placebo (matching empagliflozin) DRUG

Placebo will be taken once daily

Sequence A; Sequence B

ramipril DRUG

Ramipril will be taken once or twice daily

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

• Lytvyn Y, Kimura K, Peter N, Lai V, Tse J, Cham L, Perkins BA, Soleymanlou N, Cherney DZI. Renal and Vascular Effects of Combined SGLT2 and Angiotensin-Converting Enzyme Inhibition. Circulation. 2022 Aug 9;146(6):450-462. doi: 10.1161/CIRCULATIONAHA.122.059150. Epub 2022 Jul 11.

  PMID: 35862082 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

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

Interventions

empagliflozin; Ramipril

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: May 10, 2016
• Primary Completion: December 19, 2017
• Study Completion: July 2, 2019
• Last Updated: July 24, 2020
• Results First Posted: July 24, 2020

Record last verified: 2020-07

Locations

CA (1)