Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1)

Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1) - SiTagliptin Randomized Intervention Clinical Trial- 1(STRICT-1)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005178

Enrollment

200

Registered

2011-03-09

Start date

2011-03-01

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 Mellitus

Interventions

Sitagliptin treatment, 6 months alpha-glucosidase inhibitor treatment, 6 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients with poorly glycaemic control by sulfonylurea therapy In this study, we defined "poorly glycaemic control by sulfonylurea" as bellow. Dose of sulfonylurea: Recommemded doses by the Committee for "Reasonable use of GLP-1 analogues and DPP-4 inhibitors" Duration of sulfonylurea: current dose for over 3 months HbA1c keeps 1. 6.5% or more than 6.5% 2. Once below 6.5%, exceed 6.5% again in current 3 months' observation. HbA1c in the registration is within 6.5-8.5% Concomitant oral antidiabetic drugs: TZDs or BGs are eligible

Exclusion criteria

Exclusion criteria: 1.Contraindication for sitagliptin 2.Contraindication for alpha-glucosidase inhibitors 3.Patients treated with insulin 4.Pregnant or possible pregnant 5.Patients with severe liver failure or renal failure 6.Patients considered not eligible for the study by the attending doctor due to other reasons 7.Patients with past history of treatment of sitagliptin or other incretin related drugs

Design outcomes

Primary

Measure	Time frame
Changes of HbA1c from baseline	—

Secondary

Measure	Time frame
Fasted plasma glucose, Fasted serum insulin, Proinsulin-insulin ratio, and glucagon-induced CPR (changes from each baseline) Compliance of treatment, Adverse effects	—

Countries

Japan

Contacts

Public ContactJunji Kawashima

Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University

jkawashima@fc.kuh.kumamoto-u.ac.jp096-373-5169

Outcome results

None listed

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