Phase 2
Completed N=333
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Source: ClinicalTrials.gov NCT00309608 ↗Enrolled (actual)
333
Serious AEs
3.0%
Results posted
Jun 2011
Primary outcomePrimary: HbA1c Change From Baseline at Week 12 — 0.25; -0.15; -0.48; -0.42 Percent — p=<0.0001
Summary
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 12 |
0.25; -0.15; -0.48; -0.42; -0.59 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c<=7.0% at Week 12 |
1.4; 15.6; 14.5; 21.2; 31.3 | 0.0054 sig |
| SECONDARY Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 |
13.63; -5.32; -21.29; -15.87 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
Inclusion\_Criteria:
- Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
- HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
- HbA1c 7.5 10.0% at screening for patients treated with metformin alone
- HbA1c 7.5 10.0% at beginning of the placebo run-in phase
- Age > 21 and 25 and < 40 kg/m2 (Body Mass Index)
Exclusion criteria
Exclusion\_Criteria:
- Clinically relevant cardiovascular disease
- Impaired hepatic function
- Renal insufficiency or impaired renal function
- Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
- Treatment with insulin within 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT00309608). 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.