Defining a novel law of glucose homeostasis under Dapagliflozin usage by mathematical model approach

JRCT ID: jRCTs051180058

Registered date:14/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 30/07/2017
• Target sample size: 100
• Study type: Interventional
• Intervention(s): After use of SGLT2-inhibitor (dapagliflozin 5mg daily) , the oral glucose tolerance test and glucose clamp test are used, and we assess glucose, insulin, glucagon and c-peptide over time.

Outcome(s)

• Primary Outcome: Parameter calculated from mathematical model
• Secondary Outcome: Glucose, insulin, c-peptide, glucagon

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 75age
• Gender: Both

Include criteria

1) Type 2 diabetes mellitus
2) doctor think patients need dapagliflozin
3) non-user of other SGLT2i in one month
4) 20 to 75 years old
5) patients can understand order of take medicine
6) patients can take informed consent
7) fasting glucose controlled under 130 mg/dL

Exclude criteria

1) Plegnancy
2) a rash which one had in past illness by hypoglycemic agent or insulin
3) type 1 diabetes mellitus include SPIDDM and other diabetes
4) liver dysfunction of high grade
5) renal dysfunction of high grade
6) cardiac dysfunction of high grade
7) user of basal insulin or long-acting GLP-1 receptor agonists
8) a mentally challenged person
9) patient who made recently hypoglycemia
10) patient who dapagliflozin is administrated contraindication
11) patietnt who doctor think inadequate

Related Information

• Primary Sponsor: Sakaguchi Kazuhiko
• Source(s) of Monetary Support: AstraZeneca