Clinical Study on Diabetes supplement in participants with diabetes.

Phase 2

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

• Registration Number: CTRI/2024/04/065001
• Lead Sponsor: Emil Pharmaceutical Industries Private Limited,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Cohort 1

1. Patients diagnosed with type 2 diabetes mellitus and are taking oral hypoglycemic agents on regular basis

Cohort 2

1. Patients newly diagnosed with type II diabetes mellitus (newly diagnosed cases will be considered as those who have been diagnosed for diabetes mellitus for not more than one year) and those who are not on any oral hypoglycemic agent/insulin

For Both the Cohorts:

2.Patients having HbA1C value between 6.5 to 9.5 percent (both inclusive) at screening.

3.Patients having Fasting Plasma Glucose between 126 to 250 mg per dl (both inclusive) at screening.

4.Patients having postprandial glucose not more than 350 mg per dl at screening

5.Patient’s ECG does not demonstrate any signs of uncontrolled arrhythmia, acute ischemia.

6.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is greater 2 years post menopause.

7. Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

Exclusion Criteria

For Both Cohorts:

1. Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2

2. Patients taking Insulin for the management of Diabetes

3. Patients with known history of chronic hepatic or renal disease.

4. Patients with known history of malignancy.

5. Patients with known history of significant cardiovascular event 12 weeks prior to randomization.

6. Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.

7. Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

8. Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.

9. History of Use of any other investigational product within 1 month prior to randomization

10. Known history of hypersensitivity to ingredients used in study product

11. Pregnant and Lactating females.

12. Any other conditions which in the opinion of investigator will place the Patients at risk or will influence the conduct of study or interpretation of results

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in HbA1c percent (average change and proportion of subjects achieving target HbA1c levels below 6.5 percent). <br/ ><br>2. Change in quality of life assessed on QOLID <br/ ><br>Timepoint: Day -7, day 0, day 30, day 60 and day 90

Secondary Outcome Measures

Name	Time	Method
1. Change in FBS and PPBS (average change and proportion of subjects achieving target Fasting blood sugar of 110 mg per dl and PP blood sugar levels of 140 mg per dl). <br/ ><br>2. Change in Fasting Serum Insulin <br/ ><br>3. Change in HOMA-IR score <br/ ><br>4. Change in clinical symptoms of Type 2 DM <br/ ><br>5. Difference in requirement of Oral Hypoglycemic agents <br/ ><br>6. Monthly change in weight and BMI <br/ ><br>7. Change in global assessment for overall change by subject and investigator <br/ ><br>8. Tolerability of study products <br/ ><br>9. Change in Laboratory parameters <br/ ><br>Timepoint: Day -7, day 0, day 30, day 60 and day 90