Status:
COMPLETED
Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine
Lead Sponsor:
Universidad de Guanajuato
Collaborating Sponsors:
Hospital Regional de Alta Especialidad del Bajio
Conditions:
Prediabetic State
Impaired Glucose Tolerance
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 durat...
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 + lif...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04088461
Start Date
September 1 2016
End Date
September 1 2018
Last Update
September 13 2019
Active Locations (1)
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1
Universidad de Guanajuato
León, Guanajuato, Mexico, 37670