Clinical trial to assess the Safety and Efficacy of NRL/LP/201901 as Adjuvant Therapy in patients with Type 2 DM.

Phase 2

Completed

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

• Registration Number: CTRI/2019/05/019027
• Lead Sponsor: etsurf Communications Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-04
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients between 30-60 (both inclusive) age, both sex.

Patients receiving Oral Hypoglycemic Agents as ongoing treatment for Type 2 DM .

Hemoglobin A1c (HbA1c) >6.5% and <10% (both inclusive)

Fasting Plasma Glucose (FPG) >130 mg/dL and < 250 mg/dL (both inclusive)

Exclusion Criteria

Type 1 diabetes.

Under Insulin treatment

Patients with concurrent serious Hepatic Dysfunction (defined asAST and/or ALT >3 times of the upper normal limit) or RenalDysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

Women who are pregnant or lactating

Smokers/Alcoholics and/or drug abusers

Patients with evidence of malignancy

Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)

Involvement in any other study requiring drug therapy

Renal dysfunction as evidenced by raised serum creatinine from renal function test

History of serious arrhythmia or atrioventricular block on baseline electrocardiogram

Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)

Unwillingness to undergo therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess change from Baseline in Fasting Plasma Glucose (FPG) <br/ ><br>To assess change from Baseline in 2-hr Post-Meal Glucose (PMG) <br/ ><br>To evaluate change from Baseline in Haemoglobin A1c (HbA1c) at Week 12 (End of study). <br/ ><br>To assess change from Baseline in Fasting Insulin (FI) <br/ ><br>To assess change from Baseline in 2-hr Post-Meal Insulin (PMI)Timepoint: To assess changes in Fasting and post meal blood sugar from baseline, week4,8 and 12. <br/ ><br>Fasting and post meal To assess changes in Insulin, HbA1c baseline and end of study ie 12 week

Secondary Outcome Measures

Name	Time	Method
Changes of the b-cell functions [HOMA]-b, insulin resistance (IR) by HOMA-IR, <br/ ><br>To evaluate obesity (body weight),anthropometric parameters <br/ ><br>Change in inflammatory marker like C-peptide <br/ ><br>Safety of Diabetes Support Capsules in patients with Type 2 DM with repect to renal, liver and lipid function test. <br/ ><br>Adverse event profiling <br/ ><br>Quality of Life Instrument for Indian Diabetes Patients (QOLID)Timepoint: Subjective assessment in each follow up ie week 0, 4,8 and 12 <br/ ><br>Biochemical changes from Baseline in lipid profile to Week 12