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
|Condition or disease||Intervention/treatment||Phase|
|Prediabetic State Impaired Glucose Tolerance Insulin Resistance||Drug: Linagliptin / Metformin Oral Tablet Drug: Metformin||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Metformin 850 mg twice daily plus lifestyle modifications program
Other Name: Metformin alone
- Glucose levels during OGTT [ Time Frame: 6 months ]Glucose levels during OGTT
- Pancreatic beta cell function [ Time Frame: 6 months ]Pancreatic beta cell function measured with the disposition index during OGTT
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
|Universidad de Guanajuato|
|León, Guanajuato, Mexico, 37670|
|Principal Investigator:||Rodolfo Guardado Mendoza, MDPhD||Universidad de Guanajuato|