Diabetes Mellitus, Type 1Phase 2NCT02632747
Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
A Phase 2 study testing Empagliflozin and ramipril in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Empagliflozin and ramipril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2016to 2 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Empagliflozin, Placebo (matching empagliflozin), ramipril
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin will be taken once daily
Placebo (matching empagliflozin)Drug
Placebo will be taken once daily
ramiprilDrug
Ramipril will be taken once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril. Receives: 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. Receives: Drug: Empagliflozin; Drug: Placebo (matching empagliflozin); Drug: ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At week 4 and at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start10 May 2016
- Primary completion19 Dec 2017
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632747
- Sponsor's protocol ID
- 1245.100
- Status last verified
- Jul 2020
- First submitted
- 15 Dec 2015
- Last updated
- 24 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 35862082
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02632747
- Acronym / sponsor ID
- 1245.100
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 10 May 2016 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 24 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Empagliflozin, Drug: Placebo (matching empagliflozin), Drug: ramiprilEmpagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril. |
| Sequence B | Experimental | Drug: Empagliflozin, Drug: Placebo (matching empagliflozin), Drug: ramiprilEmpagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinEmpagliflozin will be taken once daily | Drug | Sequence A, Sequence B |
| Placebo (matching empagliflozin)Placebo will be taken once daily | Drug | Sequence A, Sequence B |
| ramiprilRamipril will be taken once or twice daily | Drug | Sequence A, Sequence B |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35862082Lytvyn 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin and ramipril in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.