drugset / Trial / NCT00622284
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2008-02
- Primary completion
- 2010-12
- Completion
- —
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Linagliptin vs Glimepiride; p = 0.0005; Least Squares Mean Difference 0.22 (97.5% CI 0.13 to 0.31); NCT00622284 ↗
paper meeting the predefined non-inferiority criterion of 0·35%. PMID 22748821 ↗
Publications
- Dennis JM, Young KG, Cardoso P, Gudemann LM, McGovern AP, Farmer A, Holman RR, Sattar N, McKinley TJ, Pearson ER, Jones AG, Shields BM, Hattersley AT; MASTERMIND Consortium. A five-drug class model using routinely available clinical features to optimise prescribing in type 2 diabetes: a prediction model development and validation study. Lancet. 2025 Mar 1;405(10480):701-714. doi: 10.1016/S0140-6736(24)02617-5. Epub 2025 Feb 25.
- Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA(1)c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.
- Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.
- Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | 1 mg | Oral |
| Comparator | Glimepiride | Small molecule | 2 mg | Oral |
| Comparator | Glimepiride | Small molecule | 3 mg | Oral |
| Comparator | Glimepiride | Small molecule | 4 mg | Oral |
| Subject | Linagliptin | Unknown | 5 mg | Oral |