Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably* more than or equal to 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial 2. Glycosylated haemoglobin A1 (HbA1c) more than or equal to 7.0 and less than or equal to 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase) 3. Age more than or equal to 18 and less than or equal to 80 years at Visit 1a (screening) 4. BMI (Body Mass Index) less than or equal to 40 kg/m2 at Visit 1a (screening) 5. Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation *Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent 2. Impaired hepatic function, defined by serum levels of either alanine transaminase, ALT (SGPT), aspartase transaminase, AST (SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a 3. Renal failure or renal impairment (serum creatinine more than or equal to 1.5 mg/dl) as determined at Visit 1a 4. Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent 5. Treatment with GLP-1 analogues (e.g. exanatide) within 3 months prior to the date of informed consent 6. Treatment with insulin within 3 months prior to the date of informed consent 7. Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent 8. Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent 9. Pre-menopausal women (last menstruation less than or equal to 1 year prior to the date of 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 periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partner. No exception will be made. 10. Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides 11. Dehydration (as confirmed by the Investigator’s clinical opinion) 12. Current acute or chronic metabolic acidosis 13. Hereditary galactose intolerance 14. Alcohol abuse within 3 months prior to the date of informed consent that, in the Investigator’s opinion, would interfere with participation in the trial 15. Drug abuse 16. Participation in another trial with an investigational product within 2 months prior to the date of informed consent 17. Any other clinical condition which, in the Investigator’s opinion, would interfere with participation in the trial and patient safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control. ;Primary end point(s): The primary endpoint is the change from baseline in HbA1c after 24 weeks of treatment, where "baseline" refers to the last observation prior to the treatment phase.;Secondary Objective: Secondary objectives include: - occurrence of a treat to target response, that is an HbA1c under treatment of < 7.0% after 24 weeks of treatment - occurrence of a treat to target response, that is an HbA1c under treatemtn of < 6.5% after 24 weeks of treatment - occurrence of a relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) - HbA1c reduction from baseline by visit over time - change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment - change from baseline in FPG by visit over time A number of "other" endpoints, as well safety endpoints have also been defined in the trial protocol. | — |
Countries
Germany, United Kingdom
Outcome results
None listed