Alternation in glucagon secretion by Sodium glucose transporter-2 inhibitor

JRCT ID: jRCTs031190010

Registered date:16/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type2 diabetes mellitus
• Date of first enrollment: 06/05/2016
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of sodium glucose transporter-2(SGLT-2) inhibitor, Luseogliflozin, and dose of Luseogliflozin is 25mg once a daily before breakfast, administration period of Luseogliflozin is 12weeks.

Outcome(s)

• Primary Outcome: To elucidate the alternation in glucagon secretion pattern by dietary intake before and after 12 weeks administration of sodium glucose transporter-2(SGLT-2) inhibitor.
• Secondary Outcome: To elucidate the change of the level of plasma glucose, insulin, glucagon related peptide, free fatty acid, and plasma ketone body in glucagon secretion pattern by dietary intake before and after 12 weeks administration of sodium glucose transporter-2(SGLT-2) inhibitor, and relationship between plasma glucagon and these parameters.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both
• Include criteria: Type 2 (non-insulin dependent) diabetes patients, aged 20 to 79, who are controlled in diet and exercise, and glycated Hb(HbA1c) is 7.0% or above and 10.0% or below.

Exclude criteria

1. A patient suffering from acute disease
2. In case of malignacy
3. Renal dysfunction (estimeted GFR <60ml/min)
4. Liver dysfunction (AST >100U/l, ALT >100U/l)
5. Pregnant or possibility of pregnant
6. Lactating mothers
7. A patient suffering from endocrine disorders
8. A patient administrated any drugs affect glucose metabolism
9. Diabetic patients who have taken any hypoglycemic agents include SGLT-2 inhibitor in proximate 6 months
10.A patient undergoing or having history of treatment for ischemic heart disease
11.Chronic heart failure (NYHA class 2 or worse)
12.A patient undergoing or having history of treatment for cerebro-vascular disease
13.A patient undergoing or multiple (3 times or more) history of urinary or genital tract infection
14.A patient accompanied with severe diabetic retinopathy, nephropathy, neuropathy
15.A patient in hyperglycemic crisis or accompanied with marked symptom of hyperglycemia
16.Taking diuretics
17.Correspond to contraindication of Luseogliflozin

Related Information

• Primary Sponsor: Ichikawa Raishi
• Source(s) of Monetary Support: Taisho Pharmaceutical Co.