Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632747
• Other study ID #: 1245.100
• Status: Completed
• Phase: Phase 2
• Start date: May 10, 2016
• Est. completion date: July 2, 2019

Study information

• Verified date: July 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2, 2019
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Drug:
• Empagliflozin
Empagliflozin will be taken once daily
• Placebo (matching empagliflozin)
Placebo will be taken once daily
• ramipril
Ramipril will be taken once or twice daily

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	At week 4 and at week 12.

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