Phase 1
Completed N=42
Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
Source: ClinicalTrials.gov NCT01703286 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28 — 0.885; 1.002; 1.002 percentage — p=0.5403
Summary
The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors.
Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28 |
0.885; 1.002; 1.002 | 0.5403 |
| SECONDARY Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28 |
1.262; 1.045; 1.009 | 0.3885 |
| SECONDARY Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28 |
1.003; 1.053; 0.981 | 0.2982 |
| SECONDARY Number of Patients With Adverse Events |
11; 25; 14; 4; 7; 7 | — |
Eligibility Criteria
Inclusion criteria
- Type 2 diabetic male and female patients according to the following criteria:
Based upon a complete medical history and clinical laboratory tests
- Age >= 18 and Age = 25 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
- Participation in another trial with an investigational drug within one month prior to administration or during the trial.
- Smoker (>= 1 cigarettes or >= 1 cigars or >= 1 pipes/day).
- Alcohol abuse (more than 60 g/day).
- Drug abuse.
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
- Excessive physical activities (within one week prior to administration or during the trial).
- Any laboratory value outside the reference range that is of clinical relevance.
Data sourced from ClinicalTrials.gov (NCT01703286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.