T2DM
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (Healthy volunteers) - free from any disease at screening - fasting plasma glucose less than 110 mg/dL at screening - BMI<27kg/m2 (T2DM volunteers) - Previous diagnosis of T2DM - No anti-diabetic medication - HbA1c (JDS) <7.5 at screening - BMI<27kg/m2
Exclusion criteria
Exclusion criteria: 1) Patients with diabetes requiring insulin therapy (insulin intensive therapy, T1DM, etc) 2) Patients treated with any anti-diabetic drugs 3) Patients with heart disease 4) Patients with renal dysfunction 5) Patients with severe hepatic dysfunction 6) Patients with history of pancreatitis 7) Patients with a history of surgery of gastrointestinal tract 8) Patients with malignant tumor(s) 9) Patients with severe infection, in the perioperative period or with serious injury 10) Excessive alcohol intake or drug abuse 11) Patients found ineligible as a study patient according to the discretion of the investigator or sub-investigator 12)Pregnant or possibly pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess effects of two glucose tolerance tests (75g OGTT and mixed meal) on following parameters in Japanese T2DM and healthy volunteers; 1) Changes in plasma glucose levels 2) Changes in serum insulin and C-peptide levels 3) Changes in plasma glucagon levels 4) Changes in plasma GIP (total, intact) levels 5) Changes in plasma GLP-1 (total, intact) levels | — |
Countries
Japan
Contacts
Kansai Electric Power Hospital Center for Diabetes, Endocrinology and Metabolism