T2DM
Conditions
Interventions
Antidiabetic treatment carried out before admission is switched to insulin therapy on admission. The dose of insulin is titrated up to achieve a target fasting plasma glucose level of less than 140 mg
Sponsors
Osaka Rosai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Japanese T2DM patients (2)Patients treated with OAD and/or injection therapy including insulin and GLP-1 receptor agonist except lixisenatide (3)HbA1c >= 7.0% at screening visit (4)Male and female patients aged 20-80 years
Exclusion criteria
Exclusion criteria: (1)Patients with history of chronic pancreatitis, inflammatory bowel disease, pancreatectomy or gastrectomy (2)Patients with history of metabolic acidosis including diabetic ketoacidosis during the previous 1 year (3)Patients with history of stroke or myocardial infarction requiring hospitalization during the previous 6 months (4)Patients with severe or uncontrolled congestive heart failure (5)Patients with drug or alcohol abuse during the previous 6 months (6)Patients having hepatic dysfunction with AST or ALT greater than 5 times the upper limit of the normal laboratory range at the time of screening (7)Patients having uncontrolled hypertension with a resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mmHg at the time of screening (8)Patients with end-stage renal dysfunction and/or dialysis (9)Patients having clinically relevant history of gastrointestinal disease with prolonged nausea and vomiting during the previous 6 months (10)Pregnant or possibly pregnant women (11)Patients judged as inadequate to participate in the present study by investingator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tlag (Tmax-cal) and T1/2 on C13-acetate breath test carried out after insulin/lixisenatide treatment | — |
Countries
Japan
Contacts
Public ContactYoshimoto Kiyohara
Osaka Rosai Hospital Center for Diabetes Mellitus
Outcome results
None listed