Skip to content

Trial · Interventional

Status unknownPhase 4Registry data

Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria

Short name EmpaSema

NCTNCT04061200 (opens ClinicalTrials.gov in a new tab)Other id2019-003175-19Other id2019
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
80 participants (estimated)
Sponsor
Steno Diabetes Center Copenhagen · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
1 Nov 2019 (estimated)
Primary completion
1 Jul 2021 (estimated)
Completion
1 Aug 2021 (estimated)
First posted
19 Aug 2019
Last update posted
19 Aug 2019
Conditions
Type 2 Diabetes With Renal Manifestations

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 4

    EmpaSema

    NCT04061200

    est. 1 Nov 2019 to est. 1 Aug 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 with placebo on albuminuria in participants with type 2 diabetes and albuminuria. In a randomised, placebo-controlled, double-blinded, parallel trial we will include 80 patients with type 2 diabetes and albuminuria. Patients will start in a run-in phase of 26 weeks with empagliflozin 25 mg alone. After that, the patients will be randomised 1:1 to an active treatment period with semaglutide of 26 weeks or placebo for 26 weeks. The primary endpoint is change from randomisation to week 52 in albuminuria, measured in three morning urine samples.

Interventions

  • Semaglutide, 1.34 mg/mLDrug
  • Placebo, 1,34 mg/mLOther
  • Empagliflozin 25 MGDrug

Arms2

  • Active comparator

    Semaglutide 1,34 mg/ml

    Semaglutide 1,34 mg/ml (solution for subcutaneous injection in pre-filled pen-injector). At randomisation, the participants start with doses of 0.25 mg/week for 4 weeks, then escalate to doses of 0.5 mg/week for 4 weeks, and thereafter escalate to 1.0 mg/week if tolerated until 52 weeks of total treatment.

  • Placebo comparator

    Placebo 1,34 mg/ml

    Placebo 1,34 mg/ml (solution for subcutaneous injection in pre-filled pen-injector). At randomisation, the participants start with doses of 0.25 mg/week for 4 weeks, then escalate to doses of 0.5 mg/week for 4 weeks, and thereafter escalate to 1.0 mg/week if tolerated until 52 weeks of total treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Albuminuria

    Time frame · From randomisation to week 52

    Registry description

    Change in albuminuria

Secondary outcomes(5)

  1. Hba1c

    Time frame · From randomisation to week 52

    Registry description

    Change in Hba1c

  2. GFR

    Time frame · From randomisation to week 52

    Registry description

    Change in measured kidney function (GFR)

  3. 24 hour blood pressure

    Time frame · From randomisation to week 52

    Registry description

    Change in 24 hour blood pressure

  4. Vasoactive hormones

    Time frame · From randomisation to week 52

    Registry description

    Change in vasoactive hormones (o Plasma renin concentration, plasma renin activity, angiotensin I, angiotensin II, aldosterone, copeptin)

  5. Inflammatory and endothelial biomarkers

    Time frame · From randomisation to week 52

    Registry description

    Change in inflammatory and endothelial biomarkers (Von Willebrand factor, sVCAM-1, sICAM-1, E-selectin, b-leucocytes, s-CRP, IL-6, osteopontin, TNF-α)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Meta-analysis (pooled) · 2024

Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.

Natale et al. 2024The Cochrane database of systematic reviewscited by 32

PMID 38770818PMC11106805DOI 10.1002/14651858.cd015588.pub2PUB-38770818

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 100 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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. 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 myocardial 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

PepBank is a research reference. Talk to a doctor before you use any peptide.