Effect of treatment with Empagliflozin alone or in combination with Semaglutide on protein in the urine in persons with type 2 diabetes and elevated urinary protein.

Phase 1

• Conditions: Type 2 diabetes with renal complications; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-003175-19-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-02
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Given written informed consent
2.Male or female patients = 18 years with type 2 diabetes (WHO criteria).
3.UACR > 100 mg/g within a year of informed consent documented in the medical files.
4.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.
5.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
6.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.
7.Ability to communicate with the investigator and understand informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Type 1 diabetes
2.Known or suspected hypersensitivity to trial product(s) or related products
3.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
4.Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and or diagnosis of unstable angina pectoris and/or myocadial infarction within the last 6 months.
5.Previous bowel resection
6.Body mass index < 18.5 kg/m2
7.Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
8.Known or suspected abuse of alcohol or narcotics.
9.Participant in another intervention study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 with placebo on albuminuria in participants with type 2 diabetes and albuminuria. ;Secondary Objective: To compare the effects of combination of empagliflozin 25 mg with either semaglutide 1.34 mg/ml or placebo treatment on: <br>•Glycaemic control<br>•Inflammation and endothelial dysfunction<br>•24h blood pressure<br>•Kidney function (GFR)<br>•Vasoactive hormones<br>;Primary end point(s): Change in albuminuria (UACR) from randomisation to end of week 52 measured in three morning spot urine samples. ;Timepoint(s) of evaluation of this end point: At randomisation and after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Change in HbA1c from randomisation to end of week 52.<br>Change in measured kidney function (GFR) from randomisation to week 52. <br>Change in 24 hour blood pressure from randomisation to week 52.<br>Change in vasoactive hormones from randomisation to week 52. <br>oPlasma renin concentration, plasma renin activity, angiotensin I, angiotensin II, aldosterone and copeptin. <br>Change in inflammatory and endothelial biomarkers from randomisation to week 52.<br>oVon Willebrand factor, sVCAM-1, sICAM-1, E-selectin, b-leucocytes, s-CRP, IL-6, osteopontin and TNF-a.<br>;Timepoint(s) of evaluation of this end point: At randomisation and after 26 weeks of treatment