Clinical trial on type 2 diabetes patients

Phase 4

Completed

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Recruitment & Eligibility

Inclusion Criteria

1. Patients in the age group of 18 to 60 years, both inclusive.

2. Patients suffering from Type II Diabetes Mellitus for more than one

year, and stabilized on mono / poly oral hypoglycemic drug underanti-diabetic therapy.

3. Patients having HbA1c value below 8% at screening.

4. Patients of female gender or non-pregnant, non-lactating females.

A urine pregnancy test is required for all female subjects of

childbearing potential unless subject has had a hysterectomy, tubal

ligation, or is > 2 years postmenopausal.

5. Patients who willing to follow the procedures as per the study

protocol and voluntarily sign an informed consent form.

Exclusion Criteria

1. Type-I & Type-II Diabetic patients who are on Insulin.

2. Known cases of severe/chronic hepatic or renal disease.

3. Known patient of any active malignancy.

4. Patients giving history of significant cardiovascular event 5.

Patients having history of known major complications of Diabetes like

Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic

wounds.

6. Patients having history of known chronic, contagious infectious

disease, such as active tuberculosis, Hepatitis B or C, or HIV.

7. Known patients of having active metabolic or gastrointestinal

diseases that may interfere with nutrient absorption, metabolism, or

excretion, excluding diabetes.

8. Patients using any other investigational drug within 1 month prior

to recruitment

9. Patients currently participating in any other clinical study

10. Any other condition due to which patients are deemed to be

unsuitable by the investigator for reason(s) not specifically stated in

the exclusion criteria

Primary Outcome Measures

Name	Time	Method
1. Evaluate changes in level of HbA1c after 12 <br/ ><br>weeks intake of KAL-10 mealTimepoint: Base line and Week 12

Secondary Outcome Measures

Name	Time	Method
1. Evaluate the effect of KAL-10 meal by <br/ ><br>observing changes on FBG and PPG and lipid <br/ ><br>profile after 12 weeks intake of KAL-10 meal <br/ ><br>2. Evaluate Changes in glucose level by <br/ ><br>continuous glucose monitoring for 2 weeks <br/ ><br>following intake of KAL-10 meal in a subset from the baseline. <br/ ><br>3. Evaluate changes in weight, body mass index <br/ ><br>after 12 week intake of KAL-10 meal <br/ ><br>Timepoint: Baseline to Week 12