Phase 3
Completed N=241
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
Source: ClinicalTrials.gov NCT01087502 ↗Enrolled (actual)
241
Serious AEs
27.2%
Results posted
Oct 2013
Primary outcomePrimary: HbA1c Change From Baseline to Week 12 — -0.11; -0.53 Percent — p=<0.0001
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline to Week 12 |
-0.11; -0.53 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline Over Time |
-0.08; -0.29; -0.09; -0.47; -0.08; -0.50 | — |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline to Week 12 |
9.53; 0.24 | 0.1602 |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline Over Time |
9.80; -10.55; 8.96; -11.25; 6.23; -6.26 | — |
| SECONDARY Percentage of Patients With HbA1c <7.0% |
11.8; 22.1; 9.1; 19.4 | — |
| SECONDARY Percentage of Patients With HbA1c <6.5% |
6.7; 9.9; 5.0; 6.1 | — |
| SECONDARY Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% |
23.3; 34.5; 24.0; 49.6 | — |
| SECONDARY Plasma Concentration of Linagliptin at Trough |
7.77; 7.62; 5.94 | — |
Eligibility Criteria
Inclusion criteria
- Type 2 diabetes mellitus
- GFR =7.0% to = 18 years
- BMI <=45 kg/m2
- Signed and dated written informed consent
Exclusion criteria
- Myocardial infarction, stroke or TIA within 3 months prior to informed consent
- Renal impairment requiring dialysis
- Bariatric surgery
- Impaired hepatic function
- Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
- Treatment with anti-obesity drugs
- Treatment with SU, glinides and metformin 8 weeks prior to informed consent
Data sourced from ClinicalTrials.gov (NCT01087502). 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.