Safety and Efficacy of TAK-559 in Combination With Metformin in Patients 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:

• Diagnosed with type 2 diabetes mellitus, and on a stable dose of an oral antidiabetic monotherapy before Screening A.
• Female patients of childbearing potential who were sexually active agreed to use adequate contraception, and could neither pregnant nor lactating from Screening throughout the duration of the study.
• Had a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10.0% at Screening B.
• Had a fasting plasma glucose greater than or equal to 126 mg/dL (7.0 mmol/L) at Screening B.
• Taking a stable dose of at least 1000 mg of metformin for at least 30 days before Screening B.
• Had a stable or worsening self-monitoring blood glucose level while taking metformin.
• Had a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A.
• Had a body mass index was less than or equal to 45 kg/m2 at Screening A.
• Was willing to be counseled by the investigator or designee to follow an individualized, weight-maintaining diet during the study period.
• Had evidence of insulin secretory capacity as demonstrated by a C-peptide concentration of greater than or equal to 1.5 ng/mL (0.50 nmol/L) at Screening A, and if necessary, after a repeat at Screening B.
• Was able to perform daily self-monitoring blood glucose tests throughout the study.
• Had a normal thyroid-stimulating hormone level of less than 5.5 μIU/mL (5.5 mIU/L) and greater than or equal to 0.35 μIU/mL (0.35 mIU/L) at Screening A.
• Was in good health as determined by a physician (ie, via medical history and physical examination), other than a diagnosis of type 2 diabetes mellitus.
• Had fasting clinical laboratory results within the normal ranges for the testing laboratory, or if not, the results were deemed not clinically significant by the investigator before Randomization.

Exclusion Criteria:

• Diagnosed with type 1 diabetes mellitus, hemochromatosis, or had a history of ketoacidosis.
• Had any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states or hemoglobinopathies).

• Took any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may have interfered with evaluation of the study medication, including:

  • Insulin
  • Oral antidiabetics including sulfonylureas and alpha-glucosidase inhibitors
  • Systemic corticosteroids
  • Warfarin
  • Rifampin
  • St. John's Wort.
  • Thiazolidinediones
  • Peroxisome proliferator-activated receptor agonists
  • Nicotinic Acid
  • Fibrates
• Had a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, clinically significant abnormal electrocardiogram, or documented cerebrovascular accident within 6 months before Screening A.
• Had abdominal, thoracic, or vascular surgery within 6 months before Screening A that in the investigator's opinion warranted exclusion from the study.
• Had a creatine phosphokinase value greater than 3 times the upper limit of normal at Screening A.
• Had persistent unexplained microscopic or macroscopic hematuria or a history of bladder cancer.
• Had a triglyceride level greater than 500 mg/dL (5.6 mmol/L) at Screening A.
• Received any alteration in allowed lipid lowering medication (dose or drug) within 2 months of Randomization, if applicable. The patient remained on a stable dose throughout the study. If deemed necessary, the dose could have been lowered with prior approval from the Sponsor.
• Donated and/or received any blood or blood products within 3 months before Randomization.
• Had a history of drug abuse or a history of alcohol abuse within 2 years before Randomization
• Had a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure of greater than 95 mm Hg at Screening B.
• Had significant cardiovascular disease including but not limited to, New York Heart Association Functional (Cardiac) Classification III or IV.
• Had a history of cancer other than basal cell or stage 1 squamous cell carcinoma of the skin that had not been in remission within 5 years before Randomization.
• Had an alanine aminotransferase or aspartate aminotransferase level greater than 3 times the upper limit of normal, active liver disease, or jaundice at Screening A.
• Had a positive anti-hepatitis B surface antigen, or anti-hepatitis B e antigen test results at Screening A.
• Was currently taking another investigational study medication or had taken an investigational study medication within 30 days before Screening A.
• Had any other serious disease or condition at Screening A or at Randomization that might have affected life expectancy or made it difficult to successfully manage and follow the patient according to the protocol.