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: Other specified diabetes mellituswithout complications,

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

Brief Summary

Diabetes mellitus (DM) is rising in India with more than 62 million diabetic individuals. India (31.7 million) topped world with highest number of people with DM followed by US. Prevalence of DM is predicted to double globally from 171 in 2000 to 366 million in 2030. The prospective clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with DM is conducted. At two sites, 30 subjects were evaluated till 60 days for Fasting Plasma Glucose (FPG), Post Meal Glucose (PMG) and HbA1c. At initial, mean FPG level was 344.70 ± 80.12 mg/dl, for day 60 it was reduced 155.80 ± 31.44 mg/dl. At baseline visit, the mean PMG level was 436.22 ± 102.73 mg/dl, for day 60 it was reduced to 204.87 ± 27.74 mg/dl and HbA1C % was 10.35 ± 1.95, for day 60 it was reduced to 7.34± 0.97 mg/dl. The reduction in clinical symptoms of patients is also reported. The success of product as an adjuvant therapy can be explained as it caused reduction in doses of insulin and OHA in test population at 60 days. It can be concluded that adjuvant therapy of Gplife Advanced Diabetic Support Tablet significantly effective in reducing levels of fasting plasma glucose (FPG) and Post meal plasma glucose (PMG) from baseline till 60 days. No significant change in any of the safety laboratory parameters and vitals was observed suggesting safety of the Gplife Advanced Diabetic Support Tablet.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-03-08
• Study Start: 2019-05-27
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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).	Baseline and end of study
To assess change from Baseline in 2 Hr. Post Meal Glucose (PMG) to 60 days.	Baseline and end of study
To evaluate change from Baseline in Haemoglobin A1c (HbA1c)	Baseline and end of study
To assess change from Baseline in Fasting Insulin (FI)	Baseline and end of study
To assess change from Baseline in 2 hr. Post Meal Insulin (PMI).	Baseline and end of study

Secondary Outcome Measures

Name	Time	Method
Reduction in dose of OHAs	To evaluate changes of [HOMA]-b, insulin resistance (IR) by HOMA-IR

Trial Locations

Locations (2)

D. Y. Patil College of Ayurved & Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Lokmanya Medical Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

D. Y. Patil College of Ayurved & Research Center

🇮🇳Pune, MAHARASHTRA, India

Dr Abhijit Shekhar

Principal investigator

9359569457

abhijitshekhar00@gmail.com