None listed
Conditions
Interventions
32 mg TAK-559 Type of group
TAK-559 32 mg will be administered in patients controlled by diet with type 2 diabetes mellitus whose diabetes has been controlled by means of diet and exercise for at least 2.5 months before selection.
Group name:placebo Type of group
TAK-559 placebo will be administered in patients controlled by diet with type 2 diabetes mellitus whose diabetes has been controlled by means of diet and exercise for at least 2.5 months before selection.
Sponsors
TAKEDA PHARMACEUTICALS,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:glycosylated hemoglobin. Measure:Change in the baseline in glycosylated hemoglobin. Timepoints:Weeks: 4, 8, 12, 16, 20 and final visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:glycosylated hemoglobin Measure:Change in the baseline in glycosylated hemoglobin Timepoints:Weeks: 4, 8, 12, 16, 20 and final visit. ; Outcome name:Fasting plasma glucose Measure:Change in baseline in fasting plasma glucose Timepoints:Weeks: 2, 4, 8, 12, 16, 20 and final visit. ; Outcome name:serum insulin. Measure:Change in baseline in serum insulin. Timepoints:Weeks: 4, 12, 16, 20 and final visit. | — |
Countries
Argentina, Brazil, Colombia, Peru, United States
Outcome results
None listed