A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes

A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes

To evaluate the efficacy of PPB-R-203-Based Meal and TK9-Based Meal on blood glucose control in 20 patients with diabetes for 2 days.

The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.

Inclusion Criteria:

1. Diabetes mellitus patient.
2. Aged between 20 to 65 years old.
3. Informed consent form signed.

Exclusion Criteria:

1. A recent history of drug or alcohol abuse.
2. Sensitivity to analogous product.
3. Serious cardiovascular disorders.
4. Participation in another clinical investigation study.
5. Ongoing influenza, autoimmune disease and other metabolic diseases.
6. Pregnant or lactating women.
7. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.