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Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial

Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial - Saitama Sitagliptin Study (3S)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003989
Enrollment
240
Registered
2010-11-11
Start date
2010-11-01
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

Glimepiride at a dose of 1 mg plus sitagliptin group Glimepiride intesification group

Sponsors

Saitama Sitagliptin Study (3S)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inadequately controlled type 2 diabetic patients who are taking sulfonylurea (glymepiride at a dose of 1 mg to 2 mg)for more than 1 month. Patients whose HbA1c ranges from 7.0% to 9.0% (JDS value).

Exclusion criteria

Exclusion criteria: 1. Patients who had diabetic ketoacidosis, or diabetic pre- and coma within 6 months of the study entry. 2. Patients who received surgery operation during the study. 3. Patients with pregnancy or Nursing mothers 4. Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl) 5. Patients who received insulin therapy 6. Patients who had a history of hypersensitivity reaction to sitagliptin 7. Patients whom the attending doctor estimated to be ineligible according to the medical rationale.

Design outcomes

Primary

MeasureTime frame
Serum C peptide concentration Intact proinsulin/insulin ratio

Secondary

MeasureTime frame
HbA1c, fasting plasma glucose, HOMA-beta LDL cholesterol, HDL chplesterol, triglyceride, urinary albumin, cystatin C, high sensitivity C-reactive protein, high molecular weight adiponectin

Countries

Japan

Contacts

Public ContactYoshimasa Aso

Dokkyo Medical University Department of Endocrinology and Metabolism

yaso@dokkyomed.ac.jp0282-86-1111

Outcome results

None listed

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