Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.

Key facts

Study ID

NCT01512979

Run by

Boehringer Ingelheim

People needed

316

Starts

2012-01-01

Expected to finish

2013-04-01

Last updated by the study team

2014-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.
• Patients must have an glycated (or glycosylated) haemoglobin (HbA1c) between 8.5% [69 millimoles per mole (mmol/mol)] and 12.0% (108 mmol/mol) at Visit 1 (Screen).
• Patients must have a Body Mass Index (BMI) of 45 kg/m2 or less at Visit 1 (Screen).
• 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.

You may not qualify if…

• Patients with, who are, who have, or who have had:
• 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.
• 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, aspartate aminotransferase, or alkaline phosphatase. Gilbert-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.
• Impaired renal function, defined as calculated creatinine clearance of less than 60 milliliters per minute (< 60 mL/min), by the Cockcroft-Gault Equation, as determined during Screen and/or Run-In Period.
• Bariatric, gastric bypass, and other gastrointestinal surgeries (including all types of gastric banding and/or LapBand) within the past two years.
• Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
• Medical history of pancreatitis.
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, haemolytic anaemia).
• Any contraindication to metformin and/or linagliptin therapies, according to local labels.
• 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.
• 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 Type 2 Diabetes Mellitus.
• 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.
• 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.
• Participation in another trial with an investigational drug within 2 months prior to informed consent.
• Any other clinical condition that would jeopardize patient safety while participating in this clinical trial in the opinion of the Investigator.
• 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.).

Where it is running

• 1218.83.11036 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 1218.83.11011 Boehringer Ingelheim Investigational Site — Chino, California, United States
• 1218.83.11001 Boehringer Ingelheim Investigational Site — Huntington Beach, California, United States
• 1218.83.11019 Boehringer Ingelheim Investigational Site — Huntington Park, California, United States
• 1218.83.11015 Boehringer Ingelheim Investigational Site — Lomita, California, United States
• 1218.83.11023 Boehringer Ingelheim Investigational Site — Norwalk, California, United States
• 1218.83.11014 Boehringer Ingelheim Investigational Site — Roseville, California, United States
• 1218.83.11031 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1218.83.11022 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 1218.83.11025 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 1218.83.11033 Boehringer Ingelheim Investigational Site — Sanford, Florida, United States
• 1218.83.11029 Boehringer Ingelheim Investigational Site — Oakwood, Georgia, United States
• 1218.83.11026 Boehringer Ingelheim Investigational Site — Owensboro, Kentucky, United States
• 1218.83.11008 Boehringer Ingelheim Investigational Site — Elkton, Maryland, United States
• 1218.83.11027 Boehringer Ingelheim Investigational Site — Freemont, Nebraska, United States
• 1218.83.11005 Boehringer Ingelheim Investigational Site — Edison, New Jersey, United States
• 1218.83.11013 Boehringer Ingelheim Investigational Site — Jacksonville, North Carolina, United States
• 1218.83.11028 Boehringer Ingelheim Investigational Site — Salisbury, North Carolina, United States
• 1218.83.11009 Boehringer Ingelheim Investigational Site — Shelby, North Carolina, United States
• 1218.83.11003 Boehringer Ingelheim Investigational Site — Franklin, Ohio, United States
• 1218.83.11024 Boehringer Ingelheim Investigational Site — Gallipolis, Ohio, United States
• 1218.83.11018 Boehringer Ingelheim Investigational Site — Columbia, South Carolina, United States
• 1218.83.11004 Boehringer Ingelheim Investigational Site — Bristol, Tennessee, United States
• 1218.83.11017 Boehringer Ingelheim Investigational Site — Chattanooga, Tennessee, United States
• 1218.83.11002 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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