NIPH Clinical Trials Search

Basic Information

Recruitment status	recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	27/07/2018
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : LY3209590 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : LY3209590 administered subcutaneously (SC) control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo administered SC

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 70age old
Gender	Both
Include criteria	Inclusion Criteria: 1. Have T2DM diagnosed at least 1 year 2. Have hemoglobin A1c (HbA1c) >=7.0% and <=10.0% with Fasting Plasma Glucose (FPG) of >=126 mg/dL, or HbA1c >=6.5% and <7.0% with FPG of >=144 mg/dL, at screening 3. Have a body weight of >=54 kg, and a body mass index of >18.5 and <=40.0 kg/m2 at screening
Exclude criteria	Exclusion Criteria: 1. Have received a total daily dose of insulin >1.2 U/kg at screening 2. Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening 3. Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction. 4. Have a history of heart block, or a repeated demonstration of abnormality in the 12-lead ECG at screening, in the opinion of the investigator, increases the risks associated with participating in the study