Phase 2
Completed N=121
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT00716092 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Weighted Mean Glucose (WMG) Change From Baseline at Day 28 — 0.1; -19.8; -26.1 mg/dL — p=<0.0001
Summary
The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weighted Mean Glucose (WMG) Change From Baseline at Day 28 |
0.1; -19.8; -26.1 | <0.0001 sig |
| PRIMARY GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28 |
0.4; 18.5; 15.3 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline at Day 28 |
-0.1; -10.9; -15.6 | 0.0283 sig |
| SECONDARY Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28 |
8.1; -98.4; -119.1 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
- Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in
Exclusion criteria
- Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
- Impaired hepatic function
- Renal insufficiency with a creatinine clearance < 50 mL/min
- Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.
Data sourced from ClinicalTrials.gov (NCT00716092). 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.