Phase 2
N=31
Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2 · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02632747 ↗Enrolled (actual)
31
Serious AEs
3.3%
Results posted
Jul 2020
Primary outcome: Primary: Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril. — 124.0; 132.5 milliliter (mL) /minutes (min) /1.73m²
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Empagliflozin (Drug); Placebo (matching empagliflozin) (Drug); ramipril (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril. |
124.0; 132.5 | — |
| 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 |
1; 0; 1; 2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02632747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.