Phase 3
Completed N=1,551
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00622284 ↗Enrolled (actual)
1,551
Serious AEs
19.2%
Results posted
Feb 2012
Primary outcomePrimary: HbA1c Change From Baseline at Week 52 — -0.36; -0.57 Percent — p=0.0005
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 52 |
-0.36; -0.57 | 0.0005 sig |
| PRIMARY HbA1c Change From Baseline at Week 104 |
-0.16; -0.36 | 0.0004 sig |
| SECONDARY Body Weight Change From Baseline at Week 52 |
-1.12; 1.38 | <0.0001 sig |
| SECONDARY Body Weight Change From Baseline at Week 104 |
-1.39; 1.29 | <0.0001 sig |
| SECONDARY Incidence of Hypoglycaemic Events up to 52 Weeks |
41; 249 | <0.0001 sig |
| SECONDARY Incidence of Hypoglycaemic Events up to 104 Weeks |
58; 280 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 |
-8.40; -15.24 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 |
-2.34; -8.72 | 0.0012 sig |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 52 |
29.6; 38.9 | 0.0004 sig |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 104 |
21.0; 28.3 | 0.0030 sig |
| SECONDARY Percentage of Patients With HbA1c <6.5% at Week 52 |
16.9; 22.7 | 0.0025 sig |
| SECONDARY Percentage of Patients With HbA1c <6.5% at Week 104 |
10.9; 14.7 | 0.0240 sig |
| SECONDARY Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 |
26.2; 33.5 | 0.0018 sig |
| SECONDARY 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 |
-28.47; -18.72 | 0.0918 |
| SECONDARY HbA1c Change at Week 4 |
-0.26; -0.33 | — |
| SECONDARY HbA1c Change at Week 8 |
-0.37; -0.58 | — |
| SECONDARY HbA1c Change at Week 12 |
-0.43; -0.75 | — |
| SECONDARY HbA1c Change at Week 16 |
-0.45; -0.78 | — |
| SECONDARY HbA1c Change at Week 28 |
-0.43; -0.74 | — |
| SECONDARY HbA1c Change at Week 40 |
-0.42; -0.69 | — |
| SECONDARY HbA1c Change at Week 52 |
-0.41; -0.63 | — |
| SECONDARY HbA1c Change at Week 65 |
-0.32; -0.53 | — |
| SECONDARY HbA1c Change at Week 78 |
-0.22; -0.43 | — |
| SECONDARY HbA1c Change at Week 91 |
-0.21; -0.43 | — |
| SECONDARY HbA1c Change at Week 104 |
-0.21; -0.41 | — |
| SECONDARY Change in Baseline Lipid Parameter Cholesterol at Week 104 |
0; 1 | — |
| SECONDARY Change in Baseline Lipid Parameter HDL at Week 104 |
1; 0 | — |
| SECONDARY Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104 |
1; 3 | — |
| SECONDARY Change in Baseline Lipid Parameter Triglyceride at Week 104 |
-11; -7 | — |
Eligibility Criteria
Inclusion criteria
- Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
- Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
- HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
- HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase
Exclusion criteria
- Myocardial infarction, stroke or transient ischemic attack (TIA)
- Impaired hepatic function
- Renal failure or renal impairment
- Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
- Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT00622284). 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.