Health Condition 1: null- Newly Diagnosed Type 2 diabetes mellitus.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Newly Diagnosed Type 2 diabetes mellitus. -Current physical examination and vital signs at screening that reveals no clinically significant abnormalities; -Willing and able to follow the instructions and procedures of the study including water intake and other investigators instruction -Willing to give written informed consent prior to admission into the study; and -If female of childbearing potential, must be using a reliable form of birth control and be willing to continue as such for the duration of the study.
Exclusion criteria
Exclusion criteria: -Patients will be excluded from the study if they meet any of the following exclusion criteria: -Type 1 diabetes mellitus -Previous history of any water born disease -Have a history suggestive of, or presence of significant, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of study drugs; -Have a history of drug or alcohol dependency or psychological disease; -Require regular use of medication (other than study medication) that interferes with the absorption and/or metabolism of study drugs (e.g., steroids); -Have any chronic illness within 2 weeks prior to screening; -Have known significant hepatic & renal impairment; -Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Improvement in subjectâ??s quality of life. â?¢ Reduction in HbA1C, Serum insulin level, body weight, Body fat, Blood sugar fasting and Post prandial of level of the Group A and Group B. Timepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Reporting of Adverse Events (AEs) & Serious Adverse Events (SAEâ??s).Timepoint: 16 weeks | — |
Countries
India
Contacts
G D Healthcare And Diabetes Care Centre