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Comparison of efficacy between DPP-4 inhibitor up-titration vs addition of acarbose in T2DM

Comparison of efficacy between DPP-4 inhibitor up-titration vs addition of acarbose in T2DM - Clinical study of combination therapy with Acarbose and DPP-4 inhibitor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005471
Enrollment
40
Registered
2011-05-02
Start date
2011-05-01
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

Acarbose 150-300mg/day for 3 months Sitagliptin 100mg/day for 3 months

Sponsors

Saitama Medical University
Lead Sponsor
Kumagaya Geka Hospita
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Type 2 Diabetes mellitus (HbA1c level: more than 6.5%, less than 10.0%) 2) Age more than 20 years 3) Patients who have been taking 50mg qd of sitagliptin for 3 months or more (50mg qd: half of approved maximum dose) 4) 2hr postprandial glucose levels: more than 200mg/dL 5) Fasting TG levels: more than 150mg/dL 6) Pts with written IC

Exclusion criteria

Exclusion criteria: 1) According to package insert descriptions (Severe ketosis, diabetic coma etc.) 2) Patients who use of other antidiabetic agents 3) Patients who use of fibrate 4) Gastrointestinal discomfort 5) Severe hepatic dysfunction or severe renal dysfunction 6) Patients judged by the investigator to be ineligible for some other reason

Design outcomes

Primary

MeasureTime frame
Lipid profile(pre-and post-meal(30min,1,2hours)triglyceride, pre- and post-meal(30min,1,2hours)chylomicron, pre- and post-meal(30min,1,2hours)VLDL, pre- and post-meal(30min,1,2hours)IDL, pre- and post-meal(30min,1,2hours)native LDL, pre- and post-meal(30min,1,2hours)small dense LDL, pre- and post-meal(30min,1,2hours)HDL

Secondary

MeasureTime frame
HbA1c, The blood glucose, insulin, proinsulin, GLP-1, GIP, glucagon level are measured before as well as after 0.5, 1, 2 hour after breakfast.

Countries

Japan

Contacts

Public ContactIkuo Inoue

Saitama Medical University Dept. of Endocrinology and Diabetology

i1901018@saitama-med.ac.jp049-276-1875

Outcome results

None listed

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