Diabetes
Conditions
Keywords
diabetes, rapid and short acting insulin secretagogue, α-glucosidase inhibitor, HbA1C, insulin
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.
Interventions
DRUGMitiglinide
10mg tablet, 10mg TID
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy
Exclusion criteria
* Type 1 diabetes patients * Patients who require treatment with insulin * Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy) * Patients with severe ketosis, diabetic coma or precoma * Patients complicated with severe hepatic diseases * Patients complicated with severe renal diseases * Patients complicated with severe hypertension * Patients complicated with severe cardiac disease * Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C (HbA1C) | -2, 0, 4, 8, 10, 12, 16, 20 week |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose level (FPG) | 0, 4, 8, 12, 16, 20 week |
| Two-hour postprandial glucose level (PPG2) | 0, 12, 20 week |
| One-hour postprandial glucose level (PPG1) | 0, 12, 20 week |
Outcome results
None listed