Clinical study on of combination therapy with a DPP-4 inhibitor and a mitiglinide/voglibose fixed-dose combination (the combination) on glycemic/metabolic responses after meals in patients with type 2 diabetic mellitus (T2DM)

UMIN ID: UMIN000012294

Registered date:14/11/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: T2DM
• Date of first enrollment: 2013/11/18
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

After an observation period of DPP-4 inhibitor treatment, patients are randomly assigned to two groups, co-administration with the combination for 2 times per day or 3 times per day for 2 2-weeks treatment period. The meal tolerance test is conducted before and at the end of the treatment periods for 3 times per day.
After an observation period of DPP-4 inhibitor treatment, patients are randomly assigned to two groups, co-administration with the combination for 2 times per day or 3 times per day for 2 2-weeks treatment period. The meal tolerance test is conducted before and at the end of the treatment periods for 3 times per day.

Outcome(s)

• Primary Outcome: Efficacy endpoints are the actual measured value of glycemic/metabolic parameters over 120 minutes after each meal, the changes from baseline and the AUC over 120 minutes after each meal of breakfast, lunch and dinner in each treatment period.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients to whom [Contraindications] in labeling for the combination apply 2) Any others who the principal investigator deems unsuitable as subjects, in consideration of any [Special caution needed] in labeling for the combination

Related Information

• Primary Sponsor: Yuri Ono Clinic, Diabetes, Internal Medicine
• Source(s) of Monetary Support: Advanced Clinical Research Organization