A STUDY OF PARALLEL DESIGN, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, CONTROLLED ON THE SAFETY AND EFFICACY OF TAK-559 COMPARED WITH PLACEBO IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS TYPE 2

TAKEDA PHARMACEUTICALS,0 个研究点目标入组 0 人开始时间: 2003年12月31日最近更新: 2023年9月4日

适应症

试验速览

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•Is diagnosed with type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, and on a stable dose of an oral anti-diabetic monotherapy prior to Screening A.
•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.
•Was taking a stable dose of at least 10 mg of glyburide for at least 10 days prior to Screening B.
•Was on a stable or worsening self-monitoring blood glucose level while taking glyburide.
•Had a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A.
•Had a body mass index 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.

•Was diagnosed with type 1 diabetes mellitus, hemochromatosis, or has a history of ketoacidosis.
•Had any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states, hemoglobinopathies).
•Was required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
•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 prior to Screening A.
•Had abdominal, thoracic, or vascular surgery within 6 months prior to Screening A that in the investigator´s opinion would warrant exclusion from the study.
•Had a creatine phosphokinase value greater than 3 times the upper limit of normal at Screening A. The creatine phosphokinase value can be retested prior to Randomization if elevated.

发起方

TAKEDA PHARMACEUTICALS,