Phase 3
Completed N=561
Japanese P III vs Voglibose and Placebo
Source: ClinicalTrials.gov NCT00654381 ↗Enrolled (actual)
561
Serious AEs
5.4%
Results posted
Aug 2011
Primary outcomePrimary: Change From Baseline in HbA1c at Week 12 — 0.63; -0.24; -0.25 Percent — p=<0.0001
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 12 |
0.63; -0.24; -0.25 | <0.0001 sig |
| PRIMARY Change From Baseline in HbA1c at Week 26 |
-0.13; -0.19; 0.19 | 0.0003 sig |
| PRIMARY Examination of Long-term Safety of Linagliptin (52-week Treatment) |
84; 81; 15; 21; 12; 19 | — |
| SECONDARY Relative Efficacy Response of HbA1c at Week 12 |
8; 42; 56; 0; 15; 18 | — |
| SECONDARY Relative Efficacy Response of HbA1c at Week 26 |
48; 54; 36; 15; 21; 7 | — |
| SECONDARY Relative Efficacy Response of HbA1c at Week 52 |
38; 29; 6; 10; 62; 62 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 |
7.4; -12.3; -13.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-5.0; -7.8; 2.0 | 0.0239 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
-3.2; -5.9 | — |
Eligibility Criteria
Inclusion criteria
- Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
- Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
- Age: >= 20 and 240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
Data sourced from ClinicalTrials.gov (NCT00654381). 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.