Clinical Trial: Effect of Linagliptin + Metformin vs Metformin Alone in Patients With Prediabetes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Linagliptin + Metformin vs Metformin Alone on the Role of Pancreatic Islet Function, Insulin Resistance and Markers of Cardiovascular Risk in Patients With Prediabetes<

Brief 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 12 months.

Detailed Summary:

The main goal of this clinical trial is to compare the effect of two different treatments during 12 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 12 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 FASTING GLUCOSE + IMPAIRED GLUCOSE TOLERANCE, 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 eve
Sponsor: Universidad de Guanajuato

Current Primary Outcome: Change from basal fasting and post2h OGTT glucose levels at 6 and 12 months [ Time Frame: 0, 6 and 12 months ]

Fasting and post-2h OGTT glucose values (mg/dl)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from basal pancreatic beta cell function at 12 months [ Time Frame: 0, 6 and 12 months ]
    Evaluated with the measurements of glucose and insulin during the oral glucose tolerance test; as well as with the glucose and insulin measurements from the hyperglycemic clamp, as the Disposition index.
  • Change from basal insulin sensitivity at 6 and 12 months [ Time Frame: 0, 6 and 12 months ]
    Insulin sensitivity evaluated during the oral glucose tolerance test by the Matsuda index, and reported as an arbitrary units.
  • Change from basal Weight at 6 and 12 months [ Time Frame: 0, 6 and 12 months ]
    Weight measurement during the study, in kg
  • Change from basal Lipid profile at 6 and 12 months [ Time Frame: 0, 6 and 12 months ]
    Fasting lipid profile measurements during the study, in mg/dl


Original Secondary Outcome: Same as current

Information By: Universidad de Guanajuato

Dates:
Date Received: December 21, 2016
Date Started: December 2015
Date Completion: August 2018
Last Updated: December 22, 2016
Last Verified: December 2016