A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF ALOGLIPTIN PLUS METFORMIN, ALOGLIPTIN ALONE, OR METFORMIN ALONE IN SUBJECTS WITH TYPE 2 DIABETES

TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,0 个研究点目标入组 0 人开始时间: 2010年5月5日最近更新: 2023年9月4日

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•1)Male or female subjects, 18 to 80 years of age with a historical diagnosis of Type 2 Diabetes Mellitus.
•2)Has been treated with diet and exercise for at least 2 months prior to Screening, and has a Glycosylated Hemoglobin concentration between 7.5% and 10.0%, inclusive at Screening.
•3)Has received less than 7 days of any antidiabetic medication within 2 months prior to Screening.
•4)Body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2 (except for Asian or Asian-descendant subjects for whom the range is between 20 and 35 kg/ m^2, inclusive).
•5)Fasting C-peptide concentration greater than or equal to 0.8 ng/mL.
•6)Regularly using other, non-excluded, medications must be on a stable dose for at least the 4 weeks prior to Screening.
•7)Females of childbearing potential and males who are sexually active agree to routinely use adequate contraception from Screening throughout the duration of the study.
•8)Able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete patient diaries.

•1)Hemoglobin less than 12 g/dL for males and less than 10 g/dL for females at Screening Visit.
•2)Has a history of any hemoglobinopathy that may affect determination of Glycosylated Hemoglobin.
•3)Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
•4)Has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
•5)Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
•6)Has systolic blood pressure greater than or equal to 150 mmHg and /or diastolic pressure greater than or equal to 90 mmHg at Screening visit.
•7)Has New York Heart Association Class III to IV heart failure.
•8)Has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 90 days prior to Screening.
•9)Has Alanine aminotransferase greater than 3 times the upper limit of normal at Screening.
•10)Has a history of alcohol or substance abuse with the 2 years prior to Screening.
•11)Serum creatinine greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.4 mg/dL for females.
•12)Has history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening.
•13)Has a history of infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus.

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