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Safety and efficacy of glinide for the treatment of type 2 diabetic patients

Safety and efficacy of glinide for the treatment of type 2 diabetic patients - Safety and efficacy of glinide for the treatment of type 2 diabetic patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003840
Enrollment
30
Registered
2010-07-01
Start date
2010-07-01
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

Mitiglinide 10mg three times daily will be added for 4 months. If the glycemic control are suboptimal (HbA1c(JDS) 6.5% or more) 2 month after the treatment, the patients will be treated with mitiglini

Sponsors

Keio University School of Medicine Department of Medicine Division of Nephrology, Endocrinology and Metabolism
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes inadequately controlled (HbA1c 6.5% or more) with diet therapy or non-insulin secretagogues

Exclusion criteria

Exclusion criteria: 1) Patients with pretreatment with sulfonyl urea within 3 months 2) Patients who need insulin therapy for the treatment of type 2 diabetes 3) Patients with severe liver dysfunction (AST and/or ALT 100IU/l or more) 4) Patients with severe renal dysfunction (Cr 2.5mg/dl or more) or patients under hemodialysis 5) Patients with uncontrolled hypertension (SBP 180mmHg or more, and/or DBP 110mmHg or more) 6) Patients with severe heart disease 7) Patients with onset of cardiovascular disease within 3 months 8) Patients with malignancy 9) Patients with allergy for glinide 10) Patients with pregnancy 11) Patients whom the doctors do not allow to participate the study

Design outcomes

Primary

MeasureTime frame
HbA1c

Secondary

MeasureTime frame
fasting plasma glucose, C-peptide, insulin, proinsulin, glycoalbumin, 1,5-AG, serum lipid profile, body weight, adverse events, oxidative stress markers, inflammatory markers, daily capillary glucose profile

Countries

Japan

Contacts

Public ContactYoshifumi Saisho

Keio University School of Medicine Department of Medicine

ysaisho@z5.keio.jp03-5363-3797

Outcome results

None listed

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