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Clinical Trials/EUCTR2013-000418-39-ES
EUCTR2013-000418-39-ES
Active, not recruiting
Not Applicable

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

FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES (FIRCAVA)0 sites3,000 target enrollmentDecember 16, 2014
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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]
DrugsGlucophage 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 CARDIOVASCULARES (FIRCAVA)
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
December 16, 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 CARDIOVASCULARES (FIRCAVA)

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 2500
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 500

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 or previous myocardial infarction in baselina EKG.
  • •\- Current renal replacement therapy
  • •\- Previous diagnosis of liver cirrhosis or chronic hepatitis\*, or an elevation of liver enzymes (AST and or AST) \>3 times normal ranges
  • •\- Previous diagnosis of Chronic Heart Failure (NYHA class III or higher)
  • •\- A prior solid organ transplant or waiting for 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-ATFUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES3,000
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EUCTR2013-000418-39-PLEVIDEM CONSULTORES SL (EVIDEM)2,000
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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
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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