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

• Status: Terminated
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Insulin; Insulin, Globin Zinc

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).

• 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.