Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: BI 10773: 10 mg tablet to be taken orally once daily
Intervention2: BI 10773: 25 mg tablet to be taken orally once daily.
Control Intervention1: Placebo matching BI 10773 10 mg: Tablet
Sponsors
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Eligibility
Inclusion criteria
Inclusion criteria: In this study, patients completing 1245.19, 1245.20, and 1245.23 studies will participate. In the earlier studies, no patients aged above 65 years were enrolled. Hence, in this study, no patients will be aged above 66 years at the time of informed consent. The protocol does not as such have any upper age limit. Main diagnosis for study entry: The study will be performed in patients previously completing trial 1245.19, 1245.20 or 1245.23. 1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy. 2. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.
Exclusion criteria
Exclusion criteria: 1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23. 2. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during last visit of preceding trial. 3. Impaired renal function defined as GFR30 ml/min (severe renal impairment, MDRD formula) as determined during last visit of preceding trial. 4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23 5. Pre-menopausal women (last menstruation greater than or equaly to 1 year prior to 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 tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner. 6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake. 7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23). 8. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the long-term safety and tolerability of BI10773 (10 and 25mg once daily). No confirmatory statistical analysis is planned, therfore no primary endpoint in a statistical sense is defined for this trial.Timepoint: To investigate the long-term safety and tolerability of BI10773 (10 and 25mg once daily). No confirmatory statistical analysis is planned, therfore no primary endpoint in a statistical sense is defined for this trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight and waist circumference: Change from baseline to week 52, 76 and EoT. Change from baseline in body weight and waist circumference by visit over time.Timepoint: Week 52, 76 and End of Treatment. By visit over time. ;Change from baseline in HbA1c.Timepoint: By visit over time.;Fasting plasma glucose (FPG): Change from baseline in fasting plasma glucose (FPG) after 52, 76 weeks of treatment and to EoT; Change from baseline in FPG by visit over time.Timepoint: After 52, 76 weeks of treatment and to End of Treatment. By visit over time.;The change from baseline in HbA1c.Timepoint: After 52, 76 weeks of treatment and to End of Treatment. | — |
Countries
Belgium, Canada, China, France, Germany, Greece, India, Ireland, Japan, Mexico, Philippines, Republic of Korea, Slovakia, Slovenia, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Pvt Ltd
Outcome results
None listed