Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study

UMIN ID: UMIN000028988

Registered date:04/09/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2017/09/04
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 8 and day 9. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. Metformin 500 mg+Miglitol 150 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 3 and day 4. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 13 and day 14.

Outcome(s)

• Primary Outcome: 24h glycemic variability percentage (GVP)
• Secondary Outcome: 24h percentage of time in target range (70~140 mg/dL) 24h mean absolute glucose (MAG) mean glucose level (24h, 00:00~06:00, 08:00~24:00) standard deviation (SD)(24h, 00:00~06:00, 08:00~24:00) coefficient of variation (CV)(24h, 00:00~06:00, 08:00~24:00) MAGE MODD ADRR HIgh blood glucose index (HBGI) Highest postprandial glucose level within 3 hours after each meal AOC (<70 mg/dL) for glycemic variability (24h)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: severe renal dysfunction (eGFR less than 45) judged to be unsuitable for participation for medical reasons

Related Information

• Primary Sponsor: General Inuyama Chuo Hospital
• Source(s) of Monetary Support: Self funding