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Efficacy and Long-Term Safety of SK-0403 as Add-on Therapy to Sulfonylurea or Biguanides in Patients With Type 2 Diabetes

Efficacy and Long-Term Safety of SK-0403 as Add-on Therapy to Sulfonylurea or Biguanides in Patients With Type 2 Diabetes

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220755
Enrollment
Unknown
Registered
2009-06-22
Start date
2009-06-22
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Type 2 Diabetes Mellitus

Interventions

investigational material(s) Generic name etc : SK-0403 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : O

Sponsors

Kowa Co., Ltd.
Lead Sponsor
Sanwa kagaku kenkyusho co.,Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with Type 2 Diabetes who have inadequate glycemic control on a Sulfonylurea or Biguanide Therapy HbA1C of >=6.5%, but < 10.0% measured during the run-in period

Exclusion criteria

Exclusion criteria: Patients with Type 1 Diabetes Mellitus Patients require insulin or oral antidiabetic drug therapy other than a Sulfonylurea or Biguanide Patients with, or a history of, clinically significant cardiac, renal, hepatic, pulmonary, pancreatic and macrovascular disease Patients have a known allergy or hypersensitivity to a Sulfonylurea or Biguanide

Design outcomes

Primary

MeasureTime frame
Efficacy and Safety—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026