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

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ClinicalTrials.gov Identifier: NCT04088461
Recruitment Status : Completed
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Hospital Regional de Alta Especialidad del Bajio
Information provided by (Responsible Party):
Rodolfo Guardado Mendoza, Universidad de Guanajuato

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prediabetic State Impaired Glucose Tolerance Insulin Resistance Drug: Linagliptin / Metformin Oral Tablet Drug: Metformin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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 Name: 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 Name: Metformin alone




Primary Outcome Measures :
  1. Glucose levels during OGTT [ Time Frame: 6 months ]
    Glucose levels during OGTT

  2. Pancreatic beta cell function [ Time Frame: 6 months ]
    Pancreatic beta cell function measured with the disposition index during OGTT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088461


Locations
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Mexico
Universidad de Guanajuato
León, Guanajuato, Mexico, 37670
Sponsors and Collaborators
Universidad de Guanajuato
Hospital Regional de Alta Especialidad del Bajio
Investigators
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Principal Investigator: Rodolfo Guardado Mendoza, MDPhD Universidad de Guanajuato
  Study Documents (Full-Text)

Documents provided by Rodolfo Guardado Mendoza, Universidad de Guanajuato:

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Responsible Party: Rodolfo Guardado Mendoza, Principal Investigator, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT04088461     History of Changes
Other Study ID Numbers: CEI-35-16
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rodolfo Guardado Mendoza, Universidad de Guanajuato:
Prediabetes
Insulin resistance
hyperglucemia
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Intolerance
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus
Endocrine System Diseases
Metformin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action