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A phase II confirmatory study of SMP-862 therapy in patients with type 2 diabetes mellitus who are concomitantly taking sulfonylureas

A phase II confirmatory study of SMP-862 therapy in patients with type 2 diabetes mellitus who are concomitantly taking sulfonylureas

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220089
Enrollment
Unknown
Registered
2005-09-12
Start date
2005-09-12
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 patients whose blood glucose levels are not adequately controlled by sulfonylurea drugs taken in addition to diet and exercise therapies

Interventions

investigational material(s) Generic name etc : SMP-862 (metformin hydrochloride) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for In

Sponsors

Dainippon Sumitomo Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus who satisfy the following inclusion criteria -Patients who are taking sulfonylurea drugs in addition to diet and exercise therapies -Patients whose HbA1c levels are 6.5% -Patients with hepatic dysfunction -Patients with renal dysfunction -Patients with severe cardiovascular or pulmonary dysfunction, patients who have other conditions which are likely to be associated with hypoxemia -Patients with a history of lactic acidosis -Patients who are dehydrated or patients who have severe gastrointestinal disorders such as diarrhoea or vomiting which are likely to cause dehydration etc.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy: HbA1c etc—

Outcome results

None listed

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