None listed
Conditions
Interventions
TAK-559 16 mg QD Type of group
TAK-559 16 mg tablets are administered orally once a day for up to 26 weeks.
Group name:Placebo Type of group
TAK-559 placebo-compatible tablets are administered, orally, once a day for up to 26 weeks.
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. Had evidence of insulin secretory capacity as demonstrated by a C-peptide concentration of greater than or equal to 1.5 ng/mL (0.50 nmol/L) at Screening A, and if necessary, after a repeat at Screening B.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Glycosylated hemoglobin. Measure:Change in 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 Baseline in Glycosylated hemoglobin. Timepoints:weeks: 4, 8, 12, 16, 20 and Final Visit | — |
Countries
Peru
Outcome results
None listed