Phase 3
Completed N=227
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Source: ClinicalTrials.gov NCT00740051 ↗Enrolled (actual)
227
Serious AEs
1.8%
Results posted
Oct 2011
Primary outcomePrimary: HbA1c Change From Baseline at Week 18 (Interim Analysis) — 0.14; -0.44 percent — p=<0.0001
Summary
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 18 (Interim Analysis) |
0.14; -0.44 | <0.0001 sig |
| PRIMARY HbA1c Change From Baseline at Week 18 (Final Analysis) |
0.21; -0.39 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) |
7.2; -13.3 | 0.0002 sig |
| SECONDARY Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) |
11.8; 23.5 | 0.0374 sig |
| SECONDARY Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) |
2.9; 8.9 | 0.1281 |
| SECONDARY Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis) |
17.8; 36.1 | 0.0046 sig |
| SECONDARY The Change in HbA1c From Baseline by Visit Over Time |
0.26; -0.21; 0.26; -0.43; 0.10; -0.38 | — |
| SECONDARY The Change in FPG From Baseline by Visit Over Time |
9.7; -8.4; 5.4; -14.3; 5.0; -12.9 | — |
Eligibility Criteria
Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)
Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
Data sourced from ClinicalTrials.gov (NCT00740051). 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.