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

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-032-04
• Lead Sponsor: TAKEDA PHARMACEUTICALS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-05-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified