None listed
Conditions
Interventions
TAK-559 and insulin Type of group
TAK-559 32 mg, tablets, orally, once a day and stable dose injection of insulin for up to 54 weeks.
Group name:Insulin Type of group
TAK-559 placebo-matching, tablets, orally, once daily and insulin stable dose injection for up to 54 weeks.
Sponsors
TAKEDA PHARMACEUTICALS,
Eligibility
Inclusion criteria
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).
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence of Adverse events. Measure:Incidence of Adverse events. Timepoints:All visits or at occurrence. ; Outcome name:Clinical safety lab tests. Measure:Clinical safety lab tests. Timepoints:Weeks 12, 24, and Final Visit. ; Outcome name:12-lead electrocardiogram. Measure:12-lead electrocardiogram. Timepoints:Weeks: 24 and Final Visit. ; Outcome name:Urinalysis. Measure:Urinalysis. Timepoints:Weeks: 12, 24, 36, 48 and Final Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change from Baseline in cholesterol. Measure:Change from Baseline in cholesterol. Timepoints:At all visits. | — |
Countries
Peru, United States
Outcome results
None listed