inaglitpin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- SLCTR/2012/004
- Lead Sponsor
- Boehringer Ingelheim India (Pvt) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- 50
1 Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation / Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial. 2. Male and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) Type 2 Diabetes Mellitus. 3. Patients who are treatment-naïve, defined as absence of any oral antidiabetic therapy, injectable glucagon-like peptide-1 agonist/ analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation. 4. Glycated haemoglobin (HbA1c) between 8.5% and 12.0% at Visit 1 (Screen). 5. Body Mass Index (BMI) of 45 kg/m2 or less at Visit 1 (Screen) 6. In the investigators opinion, patients must be reliable, honest, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
Patients with, who are, who have, or who have had: 1.Acute coronary syndrome (NSTEMI, STEMI, and unstable angina), stroke or transient ischemic attack within 3 months prior to informed consent. 2. Liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. Gilbert-Meulengracht syndrome will be permitted. 3. Impaired renal function, defined as calculated creatinine clearance of less than 60 milliliters per minute (< 60 mL/min), by the Cockcroft-Gault Equation, determined during Screen and/or Run-In Period. 4. Bariatric, gastric bypass, and other gastrointestinal surgeries ((including all types of gastric banding and/or LapBand) within the past two years. 5. Medical History of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years. 6. Medical History of pancreatitis. 7. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, haemolytic anaemia). 8. Any contraindication to metformin and/or linagliptin therapies, according to local labels. 9. Treatment with anti-obesity drugs, including over-the-counter drugs such as Alli (orlistat), 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight. 10.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 Type 2 Diabetes Mellitus. 11. Pre-menopausal women (last menstruation of 1 year or less prior to informed consent) who are nursing or pregnant, 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 trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Note: Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable, intra-vaginal, or injectable contraceptives, Essure micro-inserts placed more than six months prior to Screen Visit, complete sexual abstinence (if acceptable by local authorities), double barrier method (e.g., diaphragm or condom and spermicide), and vasectomised partner. 12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance to trial procedures or study medication intake in the opinion of the investigator. 13. Participation in another trial with an investigational drug within 2 months prior to informed consent. 14. Any other clinical condition that would jeopardize patient safety while participating in this clinical trial in the opinion of the Investigator. 15. Inability to commit to regular overnight fasting of at least 10 hours duration and attendance to study site visits between 07:00 and 11:00 ante meridiem (a.m.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c [Time Frame: 24 weeks]<br>
- Secondary Outcome Measures
Name Time Method Change from baseline in FPG after 24 weeks of treatment [Time Frame: 24 weeks ]<br>Change from baseline in HbA1c by visit over time [Time Frame: 6, 12, 18 and 24 weeks ]<br>Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 weeks of treatment) [Time Frame: 24 weeks ]<br>Occurrence of relative efficacy response (HbA1c lowering by a least 1.0% after 24 weeks of treatment) [Time Frame: 24 weeks ]<br>Occurrence of treat to target efficacy response (HbA1c <7.0%) after 24 weeks of treatment [Time Frame: 24 weeks ]<br>Change from baseline in FPG by visit over time [Time Frame: 6, 12, 18 and 24 weeks ]<br>Body weight: Change from baseline to Week 24 [Time Frame: 24 weeks]<br>HOMA indices for insulin resistance and insulin secretion (at baseline and Week 24) [Time Frame: after 24 weeks]<br>