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Effect of Linagliptin + Metformin vs Metformin Alone in Patients With Prediabetes (PRELLIM)

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ClinicalTrials.gov Identifier: NCT03004612
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Hospital Regional de Alta Especialidad del Bajio
Information provided by (Responsible Party):
Rodolfo Guardado Mendoza, Universidad de Guanajuato

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 24 months.

Condition or disease Intervention/treatment Phase
Prediabetic State Insulin Resistance Combination Product: Linagliptin + metformin Drug: Metformin Phase 4

Detailed Description:

The main goal of this clinical trial is to compare the effect of two different treatments during 24 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 24 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 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. Every 6 months OGTT will be performed on all the patients, and in a subset of patients hyperglycemic clamp will be performed at 0, 6 and 12 months. After 18 and 24 months, patients will repeat the same evaluation performed as the basal evaluation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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: Randomized Clinical Trial
Study Start Date : January 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Linagliptin + Metformin plus lifestyle
Patients are randomized to receive for 24 months Linagliptin 2.5mg + metformin 850mg every 12 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 2.5/850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
Other Name: Tradjenta Duo

Active Comparator: Metformin plus lifestyle
Patients are randomized to receive for 24 months Metformin 850mg every 12 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 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling




Primary Outcome Measures :
  1. Change from basal fasting and post2h OGTT glucose levels at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Fasting and post-2h OGTT glucose values (mg/dl)


Secondary Outcome Measures :
  1. Change from basal pancreatic beta cell function at 12 and 24 months [ Time Frame: 12 and 24 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.

  2. Change from basal insulin sensitivity at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Insulin sensitivity evaluated during the oral glucose tolerance test by the Matsuda index, and reported as an arbitrary units.

  3. Change from basal Weight at 12 and 24 months [ Time Frame: 12 and 24 months ]
    Weight measurement during the study, in kg

  4. Incidence of type 2 diabetes [ Time Frame: 24 months ]
    New reported cases with T2D according the the ADA diagnostic criteria



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 prediabetes, defined for the existence impaired glucose tolerance (Glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance test (OGTT) ) with or without impaired fasting glucose (Fasting glucose between 100 and 125 mg/dL)
  • 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.

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): NCT03004612


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:
Publications:

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Responsible Party: Rodolfo Guardado Mendoza, MDPhD, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT03004612    
Other Study ID Numbers: CEI-22-16
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rodolfo Guardado Mendoza, Universidad de Guanajuato:
prediabetes
Additional relevant MeSH terms:
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Insulin Resistance
Prediabetic State
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia
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