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Clinical Trials/EUCTR2015-003873-13-GR
EUCTR2015-003873-13-GR
Active, Not Recruiting
Phase 1

Evaluation of the tubular effects of dapagliflozin using 1HNMR spectroscopy.

Institute for the Study, Research and Education in Diabetes Mellitus and Metabolic Disorders0 sites50 target enrollmentOctober 23, 2015
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ConditionsDiabetes mellitus type 2.MedDRA version: 18.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsForxigaHYGROTON

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes mellitus type 2.
Sponsor
Institute for the Study, Research and Education in Diabetes Mellitus and Metabolic Disorders
Enrollment
50
Status
Active, Not Recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 23, 2015
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Institute for the Study, Research and Education in Diabetes Mellitus and Metabolic Disorders

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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