None listed
Conditions
Interventions
TAK-559 Type of group
TAK-559 32 mg will be administered orally.
Group name:Placebo Type of group
TAK-559 32 mg placebo will be administered orally.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients who have been diagnosed with type 2 diabetes mellitus and who are being treated with insulin therapy. The patient should have a glycosylated hemoglobin Ale (HbAlc) <8.0%, fasting plasma glucose (GPA) <140 mg / dl, and a blood pressure control (PS) reading of <140/95 mmHg at the time of treatment. selection, be willing to sign the informed consent, and meet all the inclusion criteria specified in the protocol.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have a hypersensitivity to TAK-559 or its related components, obtain clinically significant results in physical examinations, electrocardiograms (ECG), echocardiograms, or clinical laboratory results, or if they are taking any medication excluded. In case the patient presents any of the exclusion criteria specified in the protocol, he will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:adverse events safety laboratory tests 12-channel electrocardiogram urine analysis pulse and blood pressure body weight Measure:Safety measured according to patient evaluations Timepoints:throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:glucose levels Measure:Total daily insulin dose Timepoints:at each visit | — |
Countries
Peru, United States
Outcome results
None listed