Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europe

Phase 1

• Conditions: on diabetic hyperglycaemia:Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or both; MedDRA version: 17.1Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-000418-39-LT
• Lead Sponsor: FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES (FIRCAVA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-19
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

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
- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen?s disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial
- Any acute condition or exacerbation of chronic condition that would in the Investigator's opinion interfere with the initial trial visit schedule and procedures
- Known or suspected hypersensitivity to trial products or related products
- Known use of non prescribed narcotics or illicit drugs.
- Simultaneous participation in any other clinical trial of an investigational agent.
- Females of childbearing potential who are pregnant (all fertile women will be tested for before randomization), breast-feeding or intend to become pregnant.
- Presence of cataract that impedes the retinal evaluation of both eyes
- Other previously diagnosed retinal diseases
- Any diseases that would prevent the measurement of primary endpoints
- Dementia, mental disorder or evident cognitive impairment unable to give informed consent
- End-stage or metastatic cancer
- Institutionalization
- Renal function impairment: GFR <60 ml/min/1.73m2
- Contraindication to any of the study drugs (metformin or linagliptin). This includes: ALT > 3 times the upper limit of normal, history of cirrhosis or hepatitis, suspected renal artery stenosis, recent gastrointestinal bleeding (within the last year), pregnant, breastfeeding or a female of child-bearing potential not on reliable contraception and also any circumstance where ongoing medication might lead to potential adverse drug interaction with components of the trial medications.
- Any other reason, medical condition, ongoing medication or significant disability that would prevent the participant complying with trial consent, treatment and follow-up procedures or potentially jeopardise her/his medical care.
* Previous diagnosis should be documented after medical record review

Study & Design

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