None listed
Conditions
Interventions
TAK-559 and glyburide Type of group
32 mg daily of TAK-559, 16 mg of TAK-559, or of placebo to evaluate the use of TAK-559 in combination with glyburide for the treatment of patients with type 2 diabetes mellitus.
Group name:Placebo Type of group
A placebo of 32 mg daily of TAK-559 and 16 mg of TAK-559 will be administered.
Sponsors
TAKEDA PHARMACEUTICALS,
Eligibility
Inclusion criteria
Inclusion criteria: Must be 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. Has a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10.0% at Screening B. Has a fasting plasma glucose greater than or equal to 126 mg/dL (7.0 mmol/L) at Screening B. Is taking a stable dose of at least 10 mg of glyburide for at least 10 days prior to Screening B. Has a stable or worsening self-monitoring blood glucose level while taking glyburide. The patient must have a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A. Has a body mass index less than or equal to 45 kg/m2 at Screening A. Is willing to be counseled by the investigator or designee to follow an individualized, weight-maintaining diet during the study period.
Exclusion criteria
Exclusion criteria: Has been diagnosed with type 1 diabetes mellitus, hemochromatosis, or has a history of ketoacidosis. Has any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states, hemoglobinopathies). Is 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. Has 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. Has 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. Has 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change from the basal level in the level of glycosylated hemoglobin. Measure:Control glucemico de TAK-559 en pacientes diabeticos que toman gliburida y para quienes la monoterapia con un ADO (antidiabetico oral) ha resultado insuficiente. Timepoints:week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:level of glycosylated hemoglobin. Measure:Change from the beginning in the level of glycosylated hemoglobin. Timepoints:Weeks: 4, 8, 12, 16 and 20. ; Outcome name:Fasting plasma glucose (OPA) Measure:Change from baseline in fasting plasma glucose Timepoints:On all visits. | — |
Countries
Peru, United States
Outcome results
None listed