Effect of Linagliptin + Metformin vs Metformin Alone in Patients With Prediabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03004612
• Date of registration: 21/12/2016
• Prospective Registration: No
• Primary sponsor: Universidad de Guanajuato
• Public title: Effect of Linagliptin + Metformin vs Metformin Alone in Patients With Prediabetes PRELLIM
• Scientific 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
• Date of first enrolment: January 2016
• Target sample size: 144
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03004612
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Rodolfo Guardado-Mendoza, MDPhD
• Affiliation: Universidad de Guanajuato

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Insulin Resistance

Prediabetic State

Intervention(s)

Drug: Metformin

Combination Product: Linagliptin + metformin

Primary Outcome(s)

Change from basal fasting and post2h OGTT glucose levels at 12 and 24 months [Time Frame: 12 and 24 months]

Secondary Outcome(s)

Change from basal Weight at 12 and 24 months [Time Frame: 12 and 24 months]

Incidence of type 2 diabetes [Time Frame: 24 months]

Change from basal pancreatic beta cell function at 12 and 24 months [Time Frame: 12 and 24 months]

Change from basal insulin sensitivity at 12 and 24 months [Time Frame: 12 and 24 months]

Secondary ID(s)

CEI-22-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital Regional de Alta Especialidad del Bajio