Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine (RESCATHEME)

September 11, 2019 updated by: Rodolfo Guardado Mendoza, Universidad de Guanajuato

Effect of Linagliptin + Metformin on Glucose Metabolism and Pancreatic Beta Cell Function in Patients With Prediabetes Who do Not Achieve Normoglycemia After 12 Months of Treatment With Metformin Alone

The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomization and masking. Patients will be randomly assigned in a 1:1 ratio to receive linagliptin/metformin 2.5/850mg every 12 h + lifestyle modification program, or metformin 850mg every 12 h + lifestyle modification program during 6 months. Randomization will be performed using an electronic random numbers table by a Nutritionist not involved in the study. Participants and investigators involved in the patients follow-up and outcome measurements will be masked to treatment allocation during the entire study.

Patients will have a follow-up visit every month. Every appointment is about 30-45 minutes; medications tolerance and side effects will be recorded in every patients´ visit. Nutritional and physical activity assessment according to the patient´s weight will be performed by a Nutritionist every month. Monthly adherence to medications will be evaluated by pill counting; nutritional adherence and energy intake will be evaluated at 6 months by a food frequency questionnaire, and physical activity at 0 and 6 months. At basal and at 6 months patients will have an OGTT. Primary objective is to evaluate at 6 months glucose profile during OGTT, insulin secretion and pancreatic β-cell function by the OGTT DI, and regression to normoglycemia; T2D will be diagnosed and confirmed by at least two consecutive measurements of the same criteria: glycated haemoglobin ≥ 6.5 %, fasting glucose ≥ 126mg/dl, or 2 h glucose ≥ 200 mg/dl.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

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
    • Guanajuato
      • León, Guanajuato, Mexico, 37670
        • Universidad de Guanajuato

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 impaired glucose tolerance (2 h glucose between 140 - 199 mg / dL) that after 1 year of treatment with metformin at a dose of 1700 mg daily + lifestyle modifications don't achieve normoglycemia.
  • Patients who accept to participate in the study and sign informed consent.

Exclusion Criteria:

  • Patients with type 2 Diabetes diagnosted previuosly or detected during the OGTT
  • Serum creatinine > 1.6 mg/dL
  • Hypertriglyceridemia very high (>500 mg/dL)
  • Pregnancy
  • Systolic blood pressure > 180 mmHg or Diastolic blood pressure >105 mmHg (patients could be re-screened after blood pressure control)
  • 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 syndrom, 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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Linagliptin + Metformin and lifestyle
Patients with impaired glucose tolerance randomly assigned to linagliptin 2.5 mg + metftormin 850 mg every 12 hours during 6 months.
Drug: Linagliptin / Metformin Oral Tablet
Linagliptin 2.5 mg + Metformin 850 mg twice daily plus a lifestyle modifications program
Other Names:
  • Combined treatment
Active Comparator: Metformin
Patients with impaired glucose tolerance randomly assigned to metftormin 850 mg every 12 hours during 6 months.
Drug: Metformin
Metformin 850 mg twice daily plus lifestyle modifications program
Other Names:
  • Metformin alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose levels during OGTT
Time Frame: 6 months
Glucose levels during OGTT
6 months
Pancreatic beta cell function
Time Frame: 6 months
Pancreatic beta cell function measured with the disposition index during OGTT
6 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

Investigators

  • Principal Investigator: Rodolfo Guardado Mendoza, MDPhD, Universidad de Guanajuato

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

September 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-35-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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