Investigation of the renal effects of dapagliflozin regarding potential protective effects on renal function, by analysis of urine samples utilizing a method called nuclear magnetic resonance spectroscopy, used to identify molecules.

Phase 1

• Conditions: Diabetes mellitus type 2.; MedDRA version: 18.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-003873-13-GR
• Lead Sponsor: Institute for the Study, Research and Education in Diabetes Mellitus and Metabolic Disorders

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-23
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Female and/or male aged 18-70 years. Women with childbearing potential can only be included in the study if a serological pregnancy test is negative and a safe contraception method is used throughout the study.
3. Uncontrolled type 2 diabetes mellitus (HbA1c > 7%) on metformin monotherapy (= 2000 mg qd or maximum tolerated dose)
4. Stage 1 hypertension (BP 140-159/90-99 mmHg)

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1. Known primary kidney disease (eGFR < 60 ml/min)
2. History of cardiovascular disease
3. Type 1 diabetes
4. History of heart failure
5. Diseases that shorten the life expectancy (cancers, degenerative neurological disorders etc.)
6. Pregnancy-lactation
7. Patients with eGFR values lower than 45 ml/min (on repeated measurements) during the study period will be excluded

Study & Design

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