Phase 3
Completed N=241
Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01084005 ↗Enrolled (actual)
241
Serious AEs
7.9%
Results posted
Jul 2012
Primary outcomePrimary: HbA1c Change From Baseline to Week 24 — 0.04; -0.61 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 for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline to Week 24 |
0.04; -0.61 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 6 |
-0.07; -0.42 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 12 |
-0.03; -0.60 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 18 |
0.04; -0.58 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 24 |
10.1; -10.6 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 6 |
4.6; -14.1 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 12 |
6.8; -14.7 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 18 |
9.6; -12.0 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 24 |
11.5; 41.9 | — |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 24 |
11.5; 41.9 | — |
| SECONDARY Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24 |
12.8; 54.4 | — |
| SECONDARY Number of Patients With Rescue Therapy |
11; 7 | 0.0048 sig |
Eligibility Criteria
Inclusion criteria
- Type 2 diabetes mellitus
- HbA1c >= 7.0%
- Age >= 70 years
- Signed and dated written informed consent
Exclusion criteria
- Myocardial infarction, stroke or TIA within 3 months prior to informed consent
- Impaired hepatic function
- Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or pre-mixed insulins
- Treatment with anti-obesity drugs
Data sourced from ClinicalTrials.gov (NCT01084005). 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.