Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes

October 22, 2019 updated by: Rodolfo Guardado Mendoza, Universidad de Guanajuato

Effect of Low Dose Combination of Linagliptin and Metformin to Improve Pancreatic Beta Cell Function, Insulin Resistance and Cardiovascular Function in Patients With Prediabetes and Overweight/Obesity: Randomizer Clinical Trial

Type 2 diabetes is a chronic disease that has reached global epidemic proportions due to the growing number of patients in all countries; It has become the disease that causes more chronic and acute complications to patients, unfortunately, when the diagnosis of type 2 diabetes is made patients are identified at very advanced stages of the disease.

For all the above, the best strategies will be those that are aimed at early stages of the disease, and the investigators are convinced that the use the combination of drugs with additive pathophysiological effect plus cardiovascular protection in early stages, will have better results, lasting and with greater results impact on the natural history of the disease that throws measures that may have an applicability in clinical practice, in order to contribute to the control of this pathology. Therefore, the combination of medications with different mechanisms of action, in low doses, could be a useful strategy not only to prevent type 2 diabetes, but also to prevent macro and microvascular complications early. The goal of this clinical trial is to evaluate the effect of low doses 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main goal of this clinical trial is to compare the effect of two different treatments during 12 months:

  1. Lifestyle modification program + metformin 1700mg every 24 hours.
  2. Lifestyle modification program + linagliptin (2.5mg) and metformin (1700mg) every 24 hours.

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
  3. Insulin secretion, evaluated by the oral glucose tolerance in 100% of the patients
  4. Pancreatic beta cell function, evaluated by the oral glucose tolerance in 100% of the patients
  5. Cardiovascular function, evaluated by ejection fraction measurement, diastolic and systolic preloads measured by standard echocardiography.

All the patients will have a basal evaluation with an oral glucose tolerance test, lipid profile, body composition. After the basal evaluation, if the patients result with prediabetes (FASTING IMPAIRED GLUCOSE/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. After 6 months, patients will repeat the same evaluation performed as the basal evaluation.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanauato
      • León, Guanauato, Mexico, 37670
        • Recruiting
        • Universidad de Guanajuato
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with prediabetes, defined for the existence of one or both of the following conditions: 1) impaired fasting glucose (Fasting glucose between 100 and 125 mg/dL), 2) impaired glucose tolerance (Glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance test (OGTT)
  • Patients who accept to participate in the study and sign the informed consent letter.

Exclusion Criteria:

  • Patients with diagnosed Type 2 Diabetes Mellitus previously or detected during the OGTT
  • Patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin.
  • Serum creatinine > 1.6 mg/dL
  • Hypertriglyceridemia very high (>500 mg/dL)
  • Pregnant women
  • Altered arterial hypertension (Systolic > 180 mmHg or Diastolic >105 mmHg)
  • Excessive alcohol intake, acute or chronic
  • Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing's syndrome, Thyrotoxicosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Linagliptin + Metformin plus lifestyle
Patients are randomized to receive for 12 months Linagliptin 2.5mg + metformin 1700mg every 24 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the full doses. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90-150min/week.
Combination product: Linagliptin + metformin
Linagliptin-Metformin 2.5/1700mg daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
Other Names:
  • low doses of Linagliptin + metformin
ACTIVE_COMPARATOR: Metformin plus lifestyle
Patients are randomized to receive for 12 months Metformin 1700mg every 24 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the full doses. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90-150min/week.
Drug: Metformin
Metformin 1700mg daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from basal fasting and 2 hours glucose levels during the oral glucose tolerance test at 12 months
Time Frame: 12 months
Fasting and post-2 hours glucose values (mg/dl) during the oral glucose tolerance test
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from basal pancreatic beta cell function at 12 months
Time Frame: 12 months
Evaluated with the Disposition index (DI), obtained from measurements of glucose and insulin during the oral glucose tolerance test. A higher value in the DI meas a better pancreatic beta cell function. There are not minimum and maximum levels
12 months
Change from basal insulin sensitivity at 12 months
Time Frame: 12 months
Insulin sensitivity evaluated with the Matsuda Index, obtained with the insulina and glucose measurements during the oral glucose tolerance test. Matsuda index is reported in arbitrary units, and a higher value means a better insulin sensitivity. There are not minimum and maximum levels
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Guanajuato

Collaborators

Hospital Regional de Alta Especialidad del Bajio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (ACTUAL)

October 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI/HRAEB/2018/0018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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