EUCTR2011-004158-24-SK
Active, not recruiting
Phase 1
A 24-week, randomized, double-blind, active-controlled, parallel group trial to assess the superiority of oral linagliptin and metformin compared to linagliptin monotherapy in newly diagnosed, treatment naïve, uncontrolled Type 2 Diabetes Mellitus patients
Boehringer Ingelheim RCV GmbH & Co KG0 sites270 target enrollmentStarted: January 27, 2012Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 270
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Male and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) T2DM.
- •2\. Patients who are treatment\-naïve, defined as absence of any oral antidiabetic therapy, injectable GLP\-1 agonist/analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation.
- •3\. Patients must have an HbA1c between 8\.5% \[69 millimoles per mole (mmol/mol)] and 12\.0% (108 mmol/mol) at Visit 1 (Screen).
- •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 135
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 135
Exclusion Criteria
- •1\. Acute coronary syndrome (non\-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.
- •2\.Indication of 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 \[ALT or called serum glutamic pyruvic transaminase (SGPT)], aspartate aminotransferase \[AST or serum glutamic oxaloacetic transaminase (SGOT)], or alkaline phosphatase. Gilbert\-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.
- •3\.Impaired renal function, defined as calculated creatinine clearance of less than 60 milliters per minute (\< 60 mL/min), by the Cockcroft\-Gault Equation, as 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 IR 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\.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.
Investigators
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