drugset / Trial / NCT04088461
Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine
Phase 4
Completed
31 enrolled
University of Guanajuato
Hospital Regional de Alta Especialidad del Bajio · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2016-09
- Primary completion
- 2018-09
- Completion
- 2018-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linagliptin | Small molecule | 2.5 mg | Oral |
| Comparator | Metformin | Small molecule | 850 mg | — |