Type 2 Diabetes mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500 ;Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
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 GFR<30 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 <= 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 patient's safety while participating in this clinical trial. ;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 GFR<30 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 <= 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 patient's safety while participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the long-term safety and tolerability of BI 10773 (10 and 25 mg once daily);Secondary Objective: To assess the efficacy of BI 10773 (10 and 25 mg once daily) and for patients from 1245.20 of sitagliptin (100 mg once daily) for a minimum 76 weeks (incl. 24 weeks of preceding trial) compared to: • placebo as monotherapy (patients rolled over from trial 1245.20) • or placebo on a background of pioglitazone (patients rolled over from trial 1245.19) • or placebo on a background of metformin with or without sulfonylurea (patients rolled over from trial 1245.23);Primary end point(s): No primary endpoints defined in the protocol. ;Timepoint(s) of evaluation of this end point: Not applicable;Main Objective: To investigate the long-term safety and tolerability of BI 10773 (10 and 25 mg once daily);Secondary Objective: To assess the efficacy of BI 10773 (10 and 25 mg once daily) and for patients from 1245.20 of sitagliptin (100 mg once daily) for a minimum 76 weeks (incl. 24 weeks of preceding trial) compared to: • placebo as monotherapy (patients rolled over from trial 1245.20) • or placebo on a background of pioglitazone (patients rolled over from trial 1245.19) • or placebo on a background of metformin with or without sulfonylurea (patients rolled over from trial 1245.23);Primary end point(s): No primary endpoints defined in the protocol. ;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At week 52, 76 and EoT;Secondary end point(s): Endpoint(s) of safety: • Adverse events • Hypoglycaemic events • Protocol-specified significant adverse events • Cardiovascular events (Clinical Event Committee adjudication results) • Changes from baseline in clinical laboratory values • Changes from baseline of GFR • Changes from baseline of albumin/creatinine ratio • Use of rescue therapy Endpoints of efficacy (only applicable as secondary endpoints) The secondary efficacy endpoints in this study are: 1) The change from baseline in HbA1c after 52, 76 weeks of treatment and to end of treatment (EoT). Change from baseline in HbA1c by visit over time. 2) 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. 3) 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. Other exploratory efficacy endpoints are the following: • Composite endpoint of the following conditions at week 52, 76 and EoT (all three fulfilled) - Change from baseline HbA1c of more than 0.5%, i.e. < -0.5%; - Change from baseline in SBP of more than 3 mmHg, i.e., < -3 mmHg; - Percentage change from baseline in weight of more than 2%, i.e., < -2%. • Systolic and diastolic blood pressure (SBP and DBP): Change from baseline to week 52, 76 and EoT. Change from baseline in SBP and DBP by visit over time. The term "baseline" refers to the baseline values from the preceding trial, meaning the last evaluation before randomisation into the preceding trial.;Timepoint(s) of evaluation of this end point: At week 52, 76 and EoT;Secondary end point(s): Endpoint(s) of safety: • Adverse events • Hypoglycaemic events • Protocol-specified significant adverse events • Cardiovascular events (Clinical Event Committee adjudicati | — |
Countries
Belgium, Canada, China, France, Germany, Greece, India, Ireland, Japan, Korea, Republic of, Mexico, Philippines, Slovakia, Slovenia, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure;QRPE PSC CT Information Disclosure ;
Boehringer Ingelheim Pharma GmbH & Co. KG;Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed