Type 2 diabetes Mellitus MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Trajenta
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LINAGLIPTIN
CAS Number: 668270-12-0
Current Sponsor code: BI 1356
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of T2DM prior to informed consent; 2. Male and female patients on diet and exercise regimen who are drug-naïve, defined as absence of any oral antidiabetic drugs (OAD) or any injectable antidiabetic therapies for at least 12 weeks prior to randomization; 3. HbA1c of >/=7.0% (53 mmol/mol) and /=18 and =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: 1.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); 2.Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization; 3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent; 4. 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 5. Impaired renal function, defined as eGFR<60 ml/min (MDRD formula) as determined during screening or run-in phase; 5. Impaired renal function, defined as eGFR<60 ml/min (MDRD formula) as determined during screening or run-in phase; 6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malaborption; 7. Medical history of Cancer(except for basal cell carcinoma) and/or treatment for cancer within the last 5 years; 8. Blood dyscrasia or any other disorders causing hemolysis or unstable Red Blood Cell (eg. malaria, babesiosis, hamolytic anemia); 9. Known history of pancreatitis and chronic pancreatitis; 10. Contraindications to moetformin according to the local label; 11. Treatment with anti-obesity drugs 3 months prior to informed consent or any otehr treatment at the time of screening (i.e. surgery, aggressive diet regimenm etc.) leading to unstable body weight; 12. 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; 13. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who: 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 contiune using this method throughout the study and do not agree to submit to periodic pregancy testing during parcipation 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 transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. 14. Alcohol or drug abuse within 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 drgu intake; 15. Participation in another trial with application of any investigational drug within 30 days prior to informed consent; 16. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial according to investigator’s judgement;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The change from baseline in HbA1c after 14 weeks treatment;Secondary Objective: Key sencondary objectives are to assess whether the combination therapy (once daily) has improved tolerability to gastrointestinal (GI) side effects over metformin alone (twice daily), by comparing the composite endpoint of occurrence of treat to target response, defined HbA1c<7.0% and no occurence of moderate or severe metformin pre-specified GI side effects during 14 weeks treatment; and the occurrence of metformin pre-specified moderate or severe GI side effects during 14 weeks treatment.;Primary end point(s): 1: The change from baseline in Glycosylated Hemoglobin A1c (HbA1c) after 14 weeks treatment ;Timepoint(s) of evaluation of this end point: 1: 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Composite endpoint of occurence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% after 14 weeks of treatment, and no occurence of moderate or severe gastrointestinal (GI) side effects during 14 weeks of treatment 2: Change from baseline in fasting plasma glucose (FPG) after 14 weeks of treatment 3: Metformin pre-specified GI symptom intensity score assessed by investigators during 14 weeks of treatment 4: Metformin pre-specified GI symptom intensty score assessed by patients during 14 weeks of treatment 5: Composite endpoint of occurrence of treat to target efficacy response, that is an HbA1c under treatment of <6.5% after 14 weeks of treatment, and on occurence of moderate or severe metformin pre-specified GI side effects assessed by investigators 6: Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment) 7: Occurence of metformin pre-specified moderate to severe GI side effects assessed by investigators during 14 weeks of treatment 8: Occurrence of relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment) 9: Composite endponit of occurence of relative efficacy response(HbA1c lowering by at least 0.5% after 14 weeks of treatment) and no occurence of moderate and severe metformin pre-specified GI side effects assessed by the investigators during 14 weeks 10: Compostie endpoint of occurrence of relative efficacy response(HbA1c lowering by at least 0.8% after 14 weeks of treatment) and no occurrence of moderate and severe metformin pre-specified GI side effects assessed by investigators during 14 weeks 11: change from baseline in HbA1c by visit over time 12: change from baseline in body weight by visit over time ;Timepoint(s) of evaluation of this end point: 1: 14 weeks 2: 14 weeks 3: 14 weeks 4: 14 weeks 5: 14 weeks 6: 14 weeks 7: 14 weeks 8: 14 weeks 9: 14 weeks 10: 14 weeks 11: 14 weeks | — |
Countries
Belgium, Canada, China, Germany, Guatemala, Hong Kong, India, Lebanon, Mexico, Peru, Philippines, Spain, Taiwan
Contacts
Public ContactQRPE PSC CT Information Disclosure
BoehringerIngelheim Pharma GmbH & Co. KG
Outcome results
None listed