EUCTR2019-004303-12-DK
Active, not recruiting
Phase 1
The effects of SGLT2-inhibition in patients with type 2 diabetes and preserved kidney function on renal hemodynamics, kidney function and vasoactive hormones
niversity Clinic of Nephrology and Hypertension, Regional Hospital Holstebro0 sites20 target enrollmentJune 23, 2020
ConditionsType 2 diabetesMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
DrugsJardiance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 diabetes
- Sponsor
- niversity Clinic of Nephrology and Hypertension, Regional Hospital Holstebro
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Over 18 years of age
- •eGFR \> 60 ml/min
- •Type 2 diabetes diagnosed at least 1 year before inclusion and in stable Medical antidiabetic treatment for at least 3 months
- •HbA1c 48 – 70 mmol/mol
- •Fertile women are to use safe contraception
- •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 10
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Type 1 diabetes
- •Alcohol or substance abuse
- •Pregnancy or breastfeeding
- •Anamnestic or clinical signs of heart\- or liver failure
- •Active cancers, aside from skin cancers (spinocellular or basocellular carcinomas)
- •Allergies or unacceptable side effects to the experimental treatment or background treatment
- •If investigator finds the participant unfit to complete the trial
Outcomes
Primary Outcomes
Not specified
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