Study of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy Read More

Inclusion Criteria:

• Had type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, currently treated with insulin therapy.
• Required sponsor approval if older than 65 years.
• Had a Screening glycosylated hemoglobin less than or equal to 8.0%.
• Had a Screening fasting plasma glucose less than or equal to 200 mg/dL (11.1 mmol/L).
• Had a Screening low density lipoprotein less than or equal to 160 mg/dL (4.1 mmol/L).
• Had a Screening thyroid stimulating hormone level less than or equal to 5.5 μU/mL (5.5 μU/L) and greater than or equal to 0.35 μU/mL (0.35 μU/L).
• Was willing to continue dietary counseling during study and had dietary advice greater than or equal to 2.5 months prior to Screening.
• Had a Screening ejection fraction greater than or equal to 40% from echocardiogram.
• Had a Screening blood pressure less than or equal to 140/95 mm Hg.
• Was willing to perform daily self-monitoring blood glucose tests.
• A female subject of childbearing potential who was sexually active agreed to use adequate contraception, and was neither pregnant nor lactating from Screening throughout the duration of the study.
• Was in good health as determined by physician (via medical history and physical examination) other than having type 2 diabetes mellitus.
• Had clinical laboratory evaluations within normal reference range or deemed not clinically significant by the investigator or sponsor.
• Started insulin therapy at least 3 months prior to Randomization.

Exclusion Criteria:

• Had a hypersensitivity to peroxisome proliferator-activated receptor -alpha or gamma agonists, thiazolidinediones, or fibrates.
• Was diagnosed with type 1 diabetes mellitus or hemochromatosis, or had a history of ketoacidosis.
• Required greater than 2 hypertension medications to achieve adequate blood pressure control.
• Had a history of coronary angioplasty or bypass graft, or unstable angina pectoris within 1 year of Screening.
• Had a history of myocardial infarction.
• Had a history of transient ischemic attack or documented cerebrovascular accident within 6 months of Screening.
• Abdominal, thoracic, or vascular surgery within 6 months of Screening warranting exclusion (investigator's opinion).
• Had a screening creatine phosphokinase value greater than 3 times the upper limit of normal.
• Had persistent unexplained microscopic or macroscopic hematuria or history of bladder cancer.
• Had a screening triglyceride level greater than 500 mg/dL (5.6 mmol/L).
• Experienced a change in allowed lipid-lowering medication (dose or drug) within 2 months of Randomization.
• Experienced a change in blood pressure medication (dose or drug) within 1 month of Randomization.
• Had systemic corticosteroids within 1 month of Randomization.
• Had donated or received blood products within 3 months of Randomization.
• Had a condition known to invalidate glycosylated hemoglobin.
• Had a history of drug abuse or alcohol abuse within 2 years.
• Had a significant cardiovascular disease, including New York Heart Association Functional (Cardiac) Classification II, III or IV.
• Had a Screening B-Type Natriuretic Peptide greater than 100 pg/mL (100 ng/L).
• Had a history of left ventricular hypertrophy (women greater than 110 g/m2 and men greater than 134 g/m2).
• Had a clinically significant mitral insufficiency at Screening.
• Had a clinically significant aortic stenosis at Screening.
• Had a Screening body mass index greater than 45.
• Had a history of cancer with no remission within 5 years of Randomization, other than basal cell or stage 1 squamous cell carcinoma of the skin.
• Had an alanine transaminase or aspartate transaminase level greater than 3 times the upper limit of normal, active liver disease or jaundice at Screening.
• Had a positive human immunodeficiency virus, hepatitis B surface antigen, or hepatitis B e antigen test at Screening.

• Was required to take or intended to continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfered with the evaluation of the study medication, including:

  • oral antidiabetic agents (including sulfonylureas, alpha-glucosidase inhibitors, thiazolidinediones, peroxisome proliferator-activated receptor agonists and metformin)
  • fibrates
  • systemic corticosteroids
  • warfarin
  • rifampin
  • nicotinic acid
  • minoxidil
  • hydralazine
  • St. John's Wort
• Was participating or had participated in an investigational study within the past 30 days.
• Had a serious disease or condition at Screening or Randomization that could affect life expectancy or made it difficult to manage/follow patient according to protocol.