Phase 3
Completed N=503
Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
Source: ClinicalTrials.gov NCT00621140 ↗Enrolled (actual)
503
Serious AEs
3.4%
Results posted
Jun 2011
Primary outcomePrimary: HbA1c Change From Baseline at Week 24 — 0.25; -0.44 Percent — p=<0.0001
Summary
To investigate efficacy, safety and tolerability of BI 1356 versus placebo
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 24 |
0.25; -0.44 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 6 |
0.09; -0.37 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 12 |
0.16; -0.46 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 18 |
0.21; -0.45 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 24 |
14.84; -8.47 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 6 |
6.73; -10.87 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 12 |
10.23; -10.75 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 18 |
13.11; -7.25 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 24 |
11.6; 25.2 | 0.0006 sig |
| SECONDARY Percentage of Patients With HbA1c<7.0% at Week 24 |
15.3; 28.2 | — |
| SECONDARY Percentage of Patients With HbA1c <6.5% at Week 24 |
4.9; 10.6 | 0.0323 sig |
| SECONDARY Percentage of Patients With HbA1c<6.5% at Week 24 |
4.9; 10.8 | — |
| SECONDARY Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 |
19.0; 47.1 | <0.0001 sig |
| SECONDARY Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24 |
24.87; -33.51 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Male or female patients with type 2 diabetes and insufficient glycaemic control.
- Age 18 or over and not older than 80 years
Exclusion criteria
- Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
- Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.
Data sourced from ClinicalTrials.gov (NCT00621140). 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.