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Efficacy and Long-Term Safety of SK-0403 as Add-on Therapy to Insulin in Patients with Type 2 Diabetes

Efficacy and Long-Term Safety of SK-0403 as Add-on Therapy to Insulin in Patients with Type 2 Diabetes

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222199
Enrollment
Unknown
Registered
2013-08-27
Start date
2013-08-27
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

Interventions

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

Sponsors

SANWA KAGAKU KENKYUSHO CO.,LTD.
Lead Sponsor
Kowa Company, Ltd.
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes who have inadequate glycemic control on insulin therapy HbA1c(NGSP) of >= 6.9%, but < 11.0% measured during the run-in period

Exclusion criteria

Exclusion criteria: Patients with type 1 diabetes mellitus Patients with severe hypoglycemia or recurrent asymptomatic hypoglycemia Patients with, or a history of, clinically significant cardiac, renal, hepatic, pulmonary, pancreatic and macrovascular disease Patients have a known allergy or hypersensitivity to insulin

Design outcomes

Primary

MeasureTime frame
Efficacy and Safety—

Outcome results

None listed

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