Effect of Linagliptin + Metformin vs Metformin Alone in Patients With Prediabetes
Condition: Prediabetic State; Insulin Resistance
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face
      this health problem. The goal of this clinical trial is to evaluate the effect of linagliptin
      + metformin vs metformin alone on physiopathological parameters, such as glucose metabolism,
      insulin resistance, insulin secretion and pancreatic beta cell function in patients with
      impaired fasting glucose plus impaired glucose tolerance, during 24 months.
    

Detailed description: 
      The main goal of this clinical trial is to compare the effect of two different treatments
      during 24 months:

        1. Lifestyle modification program + metformin 850mg twice daily

        2. Lifestyle modification program + linagliptin (2.5mg) and metformin (850mg) twice daily

      on the following parameters, after 24 months of treatment:

        1. Glucose metabolism, evaluated by the oral glucose tolerance

        2. Insulin resistance, evaluated by the oral glucose tolerance in 100% of the patients and
           by hyperglycemic clamp in 10 % of the patients

        3. Insulin secretion, evaluated by the oral glucose tolerance in 100% of the patients and
           by hyperglycemic clamp in 10 % of the patients

        4. Pancreatic beta cell function, evaluated by the oral glucose tolerance in 100% of the
           patients and by hyperglycemic clamp in 10 % of the patients

        5. Systemic inflammation and cardiovascular risk factors, evaluated by cytokines
           interlelukin-6 (IL6), C-reactive protein (PCR), and measurement of the intima media
           thickness by ultrasound.

      All the patients will have a basal evaluation with an oral glucose tolerance test, lipid
      profile, body composition, and IMT measurement by ultrasonography; and 10 % will be invited
      for the hyperglycemic clamp. After the basal evaluation, if the patients result with IMPAIRED
      GLUCOSE TOLERANCE and have at least 2 risk factors, they will be invited to the intervention
      phase where they will be randomized to one of the two treatment groups.

      Patients will have a follow-up visit every month to review the adherence to the lifestyle
      modification program and to the medication. Every 6 months OGTT will be performed on all the
      patients, and in a subset of patients hyperglycemic clamp will be performed at 0, 6 and 12
      months. After 18 and 24 months, patients will repeat the same evaluation performed as the
      basal evaluation.
    

Intervention name(s): Linagliptin + metformin; Metformin
Intervention type(s): Combination Product; Drug
Intervention description(s): Linagliptin-Metformin 2.5/850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling; Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
Other intervention name(s): Tradjenta Duo
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prediabetes