Status:
TERMINATED
Study of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
25-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to determine the safety of TAK-559, once daily (QD), in treating subjects receiving a stable dose of insulin to control type 2 diabetes mellitus.
Detailed Description
Insulin is a primary regulator of blood glucose concentrations. A subnormal response to circulating insulin levels at target tissues leads to a decrease in insulin-mediated glucose uptake. Insulin res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT00762190
Start Date
November 1 2003
End Date
December 1 2004
Last Update
November 12 2012
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