Patients with type 2 diabetes • with insufficient glycaemic control (HbA1c = 7.5 to < 11 % at Visit 2) • with very poor glycaemic control (HbA1c = 11 %) MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment drug naïve patients or previously treated patients with not more than one oral antidiabetic drug. Antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent • Diagnosis of type 2 diabetes prior to informed consent • Glycosylated haemoglobin A1c (HbA1c) at Visit 1a (Screening): For patients undergoing wash-out (pre-treated patients): HbA1c = 7.0 to = 10.5 %. For naïve patients not undergoing wash-out: HbA1c = 7.5 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Myocardial infarction, stroke or TIA within 6 months prior to informed consent • Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) as determined at Visit 1a • Known hypersensitivity or allergy to verum or its excipients or metformin or placebo • Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent • Treatment with a GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent • Treatment with insulin within 3 months prior to informed consent • Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent • Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse • Participation in another trial with an investigational drug within 2 months prior to informed consent • 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 transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent • Renal failure or renal impairment at Visit 1a (screening) with an eGFR < 60 ml/min • Gastric bypass • Dehydration by clinical judgement of the investigator • Unstable or acute congestive heart failure • Acute or chronic metabolic acidosis (present in patient history) • Hereditary galactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the randomised part of the trial: Efficacy and safety of BI 1356 + metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naïve or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type II diabetic patients with very poor glycaemic control for 24 weeks. ;Secondary Objective: Secondary endpoints for both the randomised and open-label parts of the trial are: • The occurrence of a treat to target efficacy response, that is an HbA1c under treatment of = 7.0 % after 24 weeks of treatment • The occurrence of treat to target efficacy response, that is an HbA1c under treatment of = 6.5 % after 24 weeks of treatment • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5 % after 24 weeks of treatment) • HbA1c reduction from baseline by visit over time • The change from baseline in fasting plasma glucose (FPG, biomarker) after 24 weeks of treatment • The change from baseline in fasting plasma glucose (FPG, biomarker) by visit over time • Meal Tolerance Test (MTT): two-hour postprandial glucose value (2hPPG) at baseline, after 24 weeks of treatment and change from baseline to week 24 ;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment (for both the randomised and open-label parts of the trial). | — |
Countries
Estonia, France, Germany, Lithuania, Netherlands, Sweden
Outcome results
None listed