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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.
•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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 11/9/2020