Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2013-000418-39-AT
EUCTR2013-000418-39-AT
Active, not recruiting
Not Applicable

Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe - e-PREDICE

FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES0 sites3,000 target enrollmentNovember 20, 2014
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionson diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or bothMedDRA version: 17.1Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsGluocophage 850 mg film-coated tabletsTrajenta 5 mg film-coated tabletsJentadueto 2.5 mg/850 mg film-coated tablets

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
on diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or both
Sponsor
FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES
Enrollment
3000
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 20, 2014
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES

Eligibility Criteria

Inclusion Criteria

  • •Men and women
  • •Age 45 \-74 years
  • •Impaired Fasting Glucose (IFG): FPG 6\.1 to 6\.9mmol/l and 2\-h PG \<7\.8mmol/L; or Impaired Glucose Tolerance (IGT): FPG \<7\.0mmol/L and 2h PG \>\_7\.8 and \<11\.1 mmol/L; or both conditions;
  • •Informed consent given
  • •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 120
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 80

Exclusion Criteria

  • •Type 1 diabetes.
  • •Known\* or unknown T2D (including screen detected T2D) with or without pharmacological treatment.
  • •Use of a GLP\-1 receptor agonist (exenatide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP\-4\) inhibitor or metformin within the 3 months prior to enrolment.
  • •Use of insulin or long\-acting insulin analogue within 3 months prior to enrolment.
  • •Any previous cardiovascular or cerebrovascular clinically documented event or revascularization procedure\*.
  • •Clinical evidence of macro\-vascular complications (overt clinical cardiovascular disease) at enrolment, including angina (stable or unstable) and evidence of previous myocardial infarction in baseline EKG.
  • •Current renal replacement therapy.
  • •A previous diagnosis of liver cirrhosis or chronic hepatitis\*, or an elevation of liver enzymes (AST and or ALT) \>3 tiems normal ranges.
  • •Previous diagnosis of Chronic heart failure (NYHA class III or higher).
  • •A prior solid organ transplant or awaiting solid organ transplant.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europeon diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or bothMedDRA version: 17.1Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2013-000418-39-ESFUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES (FIRCAVA)3,000
Active, not recruiting
Phase 1
Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europeon diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or bothMedDRA version: 20.0Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2013-000418-39-PLEVIDEM CONSULTORES SL (EVIDEM)2,000
Active, not recruiting
Not Applicable
Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europeon diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or bothMedDRA version: 17.1Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2013-000418-39-BGFUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES3,000
Active, not recruiting
Phase 1
Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europeon diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or bothMedDRA version: 17.1Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2013-000418-39-LTFUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES (FIRCAVA)3,000
Active, not recruiting
Not Applicable
Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europeon diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or bothMedDRA version: 17.1Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2013-000418-39-GRFUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES3,000