Status:
UNKNOWN
Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes With Renal Manifestations
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the effect of treatment with semaglutide 1.34 mg/ml in combination with empagliflozin 25 mg, compared to treatment with empagliflozin 25 mg in combination wi...
Detailed Description
Patients with type 2 diabetes are at high risk of developing diabetic nephropathy. The most promising antidiabetic agents on the market with potential to preserve renal function are endogenous glucago...
Eligibility Criteria
Inclusion
- Given written informed consent
- Male or female patients ≥ 18 years with type 2 diabetes (WHO criteria).
- UACR \> 100 mg/g within a year of informed consent documented in the medical files.
- eGFR ≥ 30 ml/min/1.73 m2 (estimated by CKD-EPI formula) within 3 months of informed consent documented in the medical files. The eGFR measured at visit 0 has to meet the criteria as well.
- Fertile female must use chemical, hormonal and mechanical contraceptives, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening
- Treated with maximal tolerated dose of an angiotensin-converting-enzyme inhibitor or an angiotensin II receptor blocker, 4 weeks prior to randomisation. If the participants are not treated with maximal tolerated dosis the investigator will increase the dose 4 weeks prior randomisation if tolerated.
- Ability to communicate with the investigator and understand informed consent.
Exclusion
- Type 1 diabetes
- Known or suspected hypersensitivity to trial product(s) or related products
- Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
- Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months.
- Previous bowel resection
- Body mass index \< 18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
- Known or suspected abuse of alcohol or narcotics.
- Participant in another intervention study
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04061200
Start Date
November 1 2019
End Date
August 1 2021
Last Update
August 19 2019
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820