Clinical study on glycemic excursion improvements with a DPP-4 inhibitor and a glinide in patients with type 2 diabetic mellitus - a comparative efficacy analysis using continuous glucose monitoring (CGM) -

Clinical study on glycemic excursion improvements with a DPP-4 inhibitor and a glinide in patients with type 2 diabetic mellitus - a comparative efficacy analysis using continuous glucose monitoring (CGM) - - Clinical study on glycemic excursion using CGM in patients with type 2 diabetic mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009525

Enrollment

Registered

2012-12-20

Start date

2012-12-20

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

Either sitagliptin or mitiglinide will be randomly allocated in patients with type 2 diabetes mellitus being treated with acarbose. After the add-on therapy of sitagliptin / mitiglinide with acarbose,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients using acarbose as an antidiabetic medication for 8 weeks or more, in addition to diet therapies and exercise regimens for diabetes 2)Patients who have HbA1c levels from 6.2% to 7.9% (NGSP) 3)Adult patients (&#8805;20 years) at the time their consent is obtained 4)Patients to whom the significance, objectives and methods of this study have been explained, and from whom consent can be willingly obtained

Exclusion criteria

Exclusion criteria: 1)Patients to whom [Contraindications] in labeling for the experimental drugs (sitagliptin and mitiglinide formulations or sitagliptin / mitiglinide combinations) apply 2)Any others who the principal investigator deems unsuitable as subjects, in consideration of any [Special caution needed] in labeling for the experimental drugs

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoints are the CGM glycemic change parameters: distribution of blood glucose measures, mean blood glucose levels, standard deviations (SD), number of times / AUC deviations from a target blood glucose range, and the mean amplitude of glycemic excursions (MACE) in the treatment periods. Secondary endpoints are: glycemic control parameters, oxidative stress markers, and inflammation markers in the treatment periods.	—

Measure

Time frame

Primary efficacy endpoints are the CGM glycemic change parameters: distribution of blood glucose measures, mean blood glucose levels, standard deviations (SD), number of times / AUC deviations from a target blood glucose range, and the mean amplitude of glycemic excursions (MACE) in the treatment periods. Secondary endpoints are: glycemic control parameters, oxidative stress markers, and inflammation markers in the treatment periods.

—

Countries

Japan

Contacts

Public ContactErika Yamagishi

dvanced Clinical Research Organization dvanced Clinical Research Organization

erika-yamagishi@npo-acro.jp029-353-2800

Outcome results

None listed

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