Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Linagliptin: 5mg/day , 24 weeks
Control Intervention1: Metformin: greater than or equal to 1500 mg/day or MTD, 24 weeks
Control Intervention2: Pioglitazone: 45 mg/day or MTD,24 weeks
Sponsors
Boehringer Ingelheim Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Diagnosis of type 2 Diabetes Mellitus prior to Informed consent 2. Male and female patients pretreated with metformin and pioglitazone;antidiabetic therapy has to be unchanged for 12 weeks prior to Informed consent 3. Metformin therapy should be greater than or equal to1500 mg/day or on the maximum tolerated dose for 12 weeks prior to Informed consent 4. Pioglitazone therapy should be 45 mg/day or the maximum clinically acceptable dose in investigators opinion. The dose should be unchanged for 12 weeks prior to Informed consent 5. Glycosylated haemoglobin A1 (HbA1c) greater than or equal to 7.5% and less than or equal to10% at visit 1 (randomization criterion) 6. Age greater than or equal to 18 and less than or equal to 80 years at Visit 1 (Screening) 7. BMI less than or equal to 45 kg/m2 (Body Mass Index) at Visit 1(Screening). 8. Signed and dated written Informed consent by date of visit 1 in accordance with GCP and local legislation. Note: patients currently treated with a total daily dose of metformin of less than 1500 mg can be included in the trial if investigator has documented that the dose is maximum tolerated dose of metformin for that patient.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycemia with a glucose level greater than 240 mg/dl (greater than13.3mmol/L) after an overnight fasting or greater than 400 mg/dl (greater than 22.2 mmol/L)in a randomly performed measurement during placebo run in and confirmed by secondary measurement (not on the same day). 2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent. 3. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1. 4. Gastric Bypass surgery. 5. Known hypersensitivity or allergy to the investigational product or its excipients, metformin or pioglitazone. 6. Metformin and/or pioglitazone are not used in accordance with prescribing information. 7. Treatment with rosiglitazone, GLP-1 analogues, DPP-4 inhibitor or insulin within 3 months prior to informed consent 8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent 9. Alcohol or drug abuse within the 3 months prior to informed consent that in the investigators opinion would interfere with trial participation 10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent 11. Participation in another trial with an investigational drug within 2 months prior to informed consent 12. Pre-menopausal women (last menstruation less than or equal to?n1 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 transdermal patch, intrauterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomized partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c valueTimepoint: 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose (FPG)Timepoint: 24 weeks of treatment. ;Change from baseline in FPGTimepoint: Visit over time;HbA1c reduction from baselineTimepoint: Visit over time;Occurrence of a relative efficacy response (HbA1c lowering by at least 0.5 %)Timepoint: 24 weeks of treatment. ;Occurrence of a treat to target response that is an HbA1c under treatment of < 6.5 %Timepoint: 24 weeks of treatment. ;Occurrence of a treat to target response that is an HbA1c under treatment of less than 7.0 %Timepoint: 24 weeks of treatment. | — |
Countries
France, India, Philippines, United States of America
Contacts
Public ContactDr Shubhangi Desai
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed