Health Condition 1: null- Type 2 diabetic patients
Conditions
Interventions
Intervention1: BI 1356 + Metformin: (2.5 mg + 1000 mg) Twice Daily
Intervention2: BI 1356 + Metformin: (2.5 mg + 500 mg) Twice Daily
Control Intervention1: Metformin: 1000 mg Twice Daily
Sponsors
Boehringer lngelheim Taiwan Limited
SIRO Clinpharm Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent, at the latest by the date of Visit 1 (preferably to be performed at date of Visit 7 of trial 1218.46), in accordance with the GCP and local legislation 2. Patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (Visit 7)
Exclusion criteria
Exclusion criteria: Patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46 2. Pre-menopausal women (last menstruation ≤ 1 year prior to signing informed consent) who: - are nursing or pregnant, - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner and in addition for male partners a barrier method, such as the use of condom with spermicide. No exception will be made. 3. Alcohol abuse within the 3 months prior to informed consent that would interfere with study participation 4. Drug abuse that in the opinion of the investigator would interfere with trial participation 5. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the current study is to investigate the safety and efficacy of linagliptin 2.5 mg plus metformin either 500 mg or 1000 mg, twice daily in comparison to metformin 1000 mg monotherapy twice daily given for 54 weeks. The treatment modalities will be determined by the treatments from the preceding doubleblind study, depending in which study group the patient was randomised as outlined in section 4.1.2 of this protocol.Timepoint: 54 weeks.;The objective of the current study is to investigate the safety and efficacy of linagliptin 2.5 mg plus metformin either 500 mg or 1000 mg, twice daily in comparison to metformin 1000 mg monotherapy twice daily given for 54 weeks. The treatment modalities will be determined by the treatments from the preceding doubleblind study, depending in which study group the patient was randomised as outlined in section 4.1.2 of this protocol.Timepoint: 54 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? The change from baseline in HbA1c ? The occurrence of a treat to target response, that is an HbA1c under treatment of < 7.0% after 54 weeks of treatment ? The occurrence of a treat to target response, that is an HbA1c under treatment of < 6.5% after 54 weeks of treatment ? Occurrence of a relative efficacy response (HbA1c lowering by at least 0.5% after 54 weeks of treatment) ? HbA1c reduction from baseline by visit over time ? The change from baseline in fasting plasma glucose (FPG) after 54 weeks of treatment ? The change from baseline in fasting plasma glucose (FPG) by visit over timeTimepoint: 54 weeks | — |
Countries
Canada, Croatia, Estonia, France, Germany, India, Lithuania, Mexico, Netherlands, Romania, Russian Federation, Sweden, Tunisia, Ukraine
Contacts
Public ContactDr Shubhangi Desai
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed