Clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with diabetes

Phase 2

Completed

• Conditions: Health Condition 1: E139- Other specified diabetes mellituswithout complications

• Registration Number: CTRI/2019/05/019355
• Lead Sponsor: Mr Ghanshyam Goti

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients between 18-60 (both inclusive) age, both sex.

Patients receiving Oral Hypoglycemic Agents and/or insulin as on-going treatment for diabetes

Haemoglobin A1C (HbA1c) >6.5% and <14.5 % (both inclusive)

Subjects having a body mass index (BMI) of 20 to 35 kg/m2.

Fasting Plasma Glucose (FPG) >120 mg/dL and < 450 mg/dL (both inclusive)

Exclusion Criteria

•Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (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

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

•Unwillingness to undergo therapy

•Known hypersensitivity to any of the ingredients of study tablets

•Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol

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) to 60 days. <br/ ><br>To evaluate change from Baseline in Haemoglobin A1c (HbA1c) <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). <br/ ><br>Timepoint: Baseline and end of study <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Reduction in dose of OHAs <br/ ><br>To evaluate changes of [HOMA]-b, insulin resistance (IR) by HOMA-IR <br/ ><br>To evaluate C-Peptide level <br/ ><br>Evaluation of Urine sugar <br/ ><br>Subjective assessment of the clinical symptoms <br/ ><br>To evaluate tolerability and safety <br/ ><br>To assess change from Baseline in lipid profile to 60 days. <br/ ><br>Assessment of vitals during the study period <br/ ><br>Global assessment for overall improvement by the subject and investigator <br/ ><br>Quality of Life Instrument for Indian Diabetes Patients <br/ ><br>Timepoint: Baseline and 60 days