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Efficacy and Safety of TAK-559 Combined With Glyburide in Treating Subjects With Type 2 Diabetes Mellitus.

STUDY OF PARALLEL, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED DESIGN ON SAFETY AND EFFICACY OF THE COMBINATION OF TAK 559 AND GLIBENCLAMID COMPARED WITH PLACEBO AND GLIBENCLAMIDE IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS TYPE 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-031-04
Enrollment
Unknown
Registered
2004-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

TAK-559 16 mg + glyburide Type of group
TAK-559 16 mg, tablets, orally, once daily and glyburide stable dose orally, once daily for up to 26 weeks. Group name:placebo Type of group
TAK-559 placebo-matching tablets, orally, once daily and glyburide stable dose, orally, once daily for up to 26 weeks.

Sponsors

TAKEDA PHARMACEUTICALS,
Lead Sponsor

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.

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

Design outcomes

Primary

MeasureTime frame
Outcome name:Glycosylated hemoglobin level Measure:Change from Baseline in Glycosylated hemoglobin level. Timepoints:Final Visit—

Secondary

MeasureTime frame
Outcome name:Glycosylated hemoglobin level. Measure:Change from baseline in Glycosylated hemoglobin level. Timepoints:Weeks: 4, 8, 12, 16 and 20.—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)