Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: linagliptin: Once daily in the evening in combination with metformin
Mode of administration: Oral administration)
Duration : 14 weeks duration.
Control Intervention1: Metformin: Metfor
Sponsors
Boehringer Ingelheim Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation prior to participation in the trial that is prior to any trial procedure. Male and female patients on diet and exercise regimen who are drug-naïve, defined as absence of any oral antidiabetic drugs or any injectable antidiabetic therapies for at least 12 weeks prior to randomization. HbA1c of ô???7.0% (53 mmol/mol)and ô???10.0% (86 mmol/mol)at Visit 1 i.e screening. Age ô???18 and ô???65 years at Visit 1 BMI ô???45 kg/m2 (Body Mass Index) at Visit 1
Exclusion criteria
Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level 240 mg/dl (13.3mmol/L) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (Not on the same day) Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomisation Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent Indication of liver disease / 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 during screening and/or run-in phase Impaired renal function, defined as eGFR60 ml/min ( MDRD formula) as determined during screening or run-in phase. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia) Known history of pancreatitis and chronic pancreatitis. Contraindications to metformin according to the local label. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen in the discretion of investigators, etc.) leading to unstable body weight. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM. Pre-menopausal women (last menstruation a. are nursing or pregnant or b. 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 or who do not agree to continue contraception for at least 30 days after the last dose of study drug. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives,complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner. Alcohol or drug abuse in the discretion of investigators 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. Participation in another trial with application of any investigational drug within 30 days prior to informed consent. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial according to investigatorâ??s judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c after 14 weeks treatment in patients who tolerate a daily metformin dose of at least 1000mg after two weeks of treatment (visit 4).Timepoint: 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of metformin pre-specified moderate or severe GI side effects assessed by investigators during 14 weeks of treatmentTimepoint: 14 weeks;Composite endpoint of occurrence of treat to target efficacy response, that is an HbA1c under treatment of 7.0% after 14 weeks of treatment, and no occurrence of moderate or severe metformin pre-specified GI side effects assessed by investigator during 14 weeks of treatment Timepoint: 14 weeks | — |
Countries
Bangladesh, Belgium, Canada, China, Germany, Guatemala, Hong Kong, India, Lebanon, Mexico, Peru, Philippines, Spain, Taiwan
Contacts
Public ContactDr Partha Gokhale
Outcome results
None listed