Vildagriptin versus metformin adding to the inadequate controled type 2 diabetes with multiple daily insulin injection (VMAT)

UMIN ID: UMIN000024663

Registered date:01/11/2016

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 2014/12/17
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Adding vildagriptin 100mg to the type 2 diabetes patients with multiple daily injection.
Adding metformin 1500mg to the type 2 diabetes patients with multiple daily injection.

Outcome(s)

• Primary Outcome: Daily glucose fluctuation (MAGE,SD)
• Secondary Outcome: incidence of hypoglycemia, change of HbA1c,Ratio of bolus inslin and basal insulin

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (1) Type 1 diabetes mellitus patients (2) Patients with severe liver disease (3) Patients with severe renal disease (4) Patients who had myocardial infarction within 3 months, or obvious heart failure case (5) Patients with severe pancreas disease (6) Patients having a cancer (7) Patients with hemoglobin (Hb) less than 11 g/dL (8) Patients that the number of the platelets is less than 100,000 /mm3 (9) Patients with high diabetic neuropathy (10) Patients having a proliferative retinopathy (11) Patients with a serious infectious disease or a serious injury (12) Patients with bowel disease or ileus factors (13) Chronic enteropathy patients with the digestion and absorption abnormality (14) Excessive common custom drinker (15) A pregnant woman or the woman who may be pregnant (16) Patients who was infected with hepatitis B virus or hepatitis C virus (17) In addition, the patient who judged inappropriate by an attendant physician

Related Information

• Primary Sponsor: Toho University
• Source(s) of Monetary Support: Toho University