Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity

Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity - Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025036

Enrollment

Registered

2016-12-01

Start date

2016-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Insulin therapy + miglitol 50mg thrice a day Insulin therapy + sitagliptin 50mg once a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes who are admitting to Department of Diabetes, Endocrinology and Metabolism of Nippon Medical School Hospital for glycemic control 2.HbA1c >= 8.0 % on admission and insulin therapy started during hospitalization 3.Patients with obesity who BMI>=25 on admission

Exclusion criteria

Exclusion criteria: 1. type 1 diabetes 2. with severe or asymptomatic hypoglycemic episodes 3. severe hepatic disorders 4. with viral hepatitis 5. severe renal disease 6. severe heart failure or acute coronary syndrome within the previous 6 months 7. acute or chronic pancreatitis 8. malignant tumors 9. infectious diseases, under consideration of operations or with traumatic diseases 10. severe diabetic neuropathy 11. severe diabetic retinopathy 12. with ketoacidosis or severe hyperglycemic states 13. inflammatory bowel diseases, ileus or past history of ileus 14. chronic bowel diseases with malabsorption 15. with diseases which may grow worth by bowel gas retention 16. gastrectomy 17. lactose intolerance 18. massive alcohol intake 19. pregnancy, lactation or candidates 20. patients under ongoing other clinical trials or under those within 4 months 21. severe hepatic disorders, renal disease or heart failure that seeks to influence safety 22. patients with drug hypersensitivity 23. patients who are judged as inappropriate for inclusion by physicians

Design outcomes

Primary

Measure	Time frame
Before and after 7 days administration of miglitol, sitagliptin 1. changes in respiratory metabolism function (energy consumption volume and respiratory quotient) 2. changes in active GIP and active GLP-1	—

Secondary

Measure	Time frame
1. Body weight and waist circumference, amount of visceral fat (Before, on discharge, 1 month after, 3 months after, 6 months after administration of miglitol, sitagliptin) 2. Blood glucose and CPR by meal tolerance test (Before and after 7 days administration of miglitol, sitagliptin) 3. Miglitol blood concentration (after 7 days administration of miglitol) 4. Blood pressure and AST, ALT, gamma-GTP, LDH, CPK, TP, Alb, BUN, Cr, TC, HDL-C, TG, apo protein, blood count, blood glucose, HbA1c, GA, CPR, catecholamine, urinary CPR, urinary BUN, urinary Cr, urinary albumin 5. Correlation between actual value of visceral fat area using abdominal computed tomographic scan and estimate value of visceral fat area using abbreviated visceral fat meter	—

Measure

Time frame

1. Body weight and waist circumference, amount of visceral fat (Before, on discharge, 1 month after, 3 months after, 6 months after administration of miglitol, sitagliptin) 2. Blood glucose and CPR by meal tolerance test (Before and after 7 days administration of miglitol, sitagliptin) 3. Miglitol blood concentration (after 7 days administration of miglitol) 4. Blood pressure and AST, ALT, gamma-GTP, LDH, CPK, TP, Alb, BUN, Cr, TC, HDL-C, TG, apo protein, blood count, blood glucose, HbA1c, GA, CPR, catecholamine, urinary CPR, urinary BUN, urinary Cr, urinary albumin 5. Correlation between actual value of visceral fat area using abdominal computed tomographic scan and estimate value of visceral fat area using abbreviated visceral fat meter

—

Countries

Japan

Contacts

Public ContactKyoko Inagaki

Nippon Medical School Hospital, Tokyo, Japan Department of Diabetes, Endocrinology and Metabolism

s3068@nms.ac.jp03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026