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Efficacy of Sitagliptin on glycaemic control in drug naïve patients with type 2 diabetes (STRICT-2)

Efficacy of Sitagliptin on glycaemic control in drug naïve patients with type 2 diabetes (STRICT-2) - SiTagliptin Randomized Intervention Clinical Trial - 2(STRICT-2)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005460
Enrollment
300
Registered
2011-04-18
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, 3 months Glinides treatment, 3 months Metformin treatment, 3 months

Sponsors

STRICT study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Drug naïve patients with type 2 diabetes who are poorly glycaemic controlled by lifestyle intervention. HbA1c: >6.5%, <9.0%

Exclusion criteria

Exclusion criteria: 1.Contraindication for sitagliptin 2.Contraindication for glinides 3.Contraindication for metformin 4.Patients treated with insulin 5.Pregnant or possible pregnant 6.Patients with sever liver failure or renal failure 7.Patients considered not eligible for the study by the attending doctor due to other reasons

Design outcomes

Primary

MeasureTime frame
Changes of HbA1c from baseline—

Secondary

MeasureTime frame
Fasted plasma glucose, Fasted serum insulin, Compliance of treatment, Adverse effects—

Countries

Japan

Contacts

Public ContactKayo Takeda

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

096-373-5169

Outcome results

None listed

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