International Conference On Harmonization Guidelines

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Introduction

This protocol is prepared for a human research trial. Based on this document, the trial will be conducted in Canada and on Canadian residents or citizens, according to Good Clinical Practice part of International Conference on Harmonization guidelines (ICH/GCP E6), Health Canada Regulations (Part C, Division 5) applicable government regulations. Metformin is available in Canada as Apo-Metformin but Vildagliptin (Glavus) is not available in Canada and is needed to shipping from US under the Health Canada Regulations (Part C, Division 5).

1.1 Background
Diabetes mellitus is a common diseases in the world and Canada is diabetes mellitus. Diabetes Mellitus has been starting to grow all over the world. It is anticipated that the incidence of this disease will be increased dramatically in the next decade. The main reasons of this event are obesity, increasing the population mean age and reducing physical activities especially in industrialized countries. CCDSS has reported that in adult people who are over 20 years old, the prevalence of diabetes mellitus rate was 8.7% (95% CI: 8.72-8.74%), indicating one diabetic patient in 11 healthy Canadians A , B[3, 14].
The common sort of diabetes disease is Diabetes mellitus type 2 (T2DM) that covers the 90% diabetic cases. It is a metabolic disorder that is determined by hyperglycemia (high level of blood sugar) as a result of resistance to insulin in cell membrane and relative lack of insulin [2, 10]. Type 2 diabetes is a
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