Drug Res (Stuttg) 2021; 71(06): 302-306
DOI: 10.1055/a-1388-5415
Original Article

Thymoquinone with Metformin Decreases Fasting, Post Prandial Glucose, and HbA1c in Type 2 Diabetic Patients

Shoukath M. Ali
1  Jina Pharmaceuticals Inc., Libertyville, IL, USA
,
Paul Chen
1  Jina Pharmaceuticals Inc., Libertyville, IL, USA
,
Saifuddin Sheikh
1  Jina Pharmaceuticals Inc., Libertyville, IL, USA
,
Ateeq Ahmad
1  Jina Pharmaceuticals Inc., Libertyville, IL, USA
,
Moghis Ahmad
1  Jina Pharmaceuticals Inc., Libertyville, IL, USA
,
Mahesh Paithankar
2  Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
,
Brijesh Desai
2  Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
,
Piyush Patel
2  Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
,
Mujtaba Khan
2  Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
,
Alok Chaturvedi
2  Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
,
Ronak Patel
3  Lambda Therapeutics Research Limited, Ahmedabad, Gujarat, India
,
Dharmendra T. Panchal
4  Samvedna Hospital Multispecialty, Ahmedabad, Gujarat, India
,
Kuntal Shah
5  Bodyline Hospitals, Ahmedabad, Gujarat, India
,
Vipul Chavda
6  Rudraksha Hospital, Bareja, Gujarat, India
,
Banshi D. Saboo
7  Bakeri Medical Research Center, Ahmedabad, Gujarat, India
,
Alpesh Patel
8  Shree Nidhi Heart & Medial Hospital, Mehsana, Gujarat, India
,
Imran Ahmad
1  Jina Pharmaceuticals Inc., Libertyville, IL, USA
› Author Affiliations

Abstract

Objective Antihyperglycemic activity of Thymoquinone (TQ) was evaluated in diabetic mouse model and patients.

Methods TQ (50 mg/kg) was orally administered daily for 21 days in combination with metformin in diabetic mice and a reduction on blood glucose level was monitored. In human, a 90-day randomized study was carried out in 60 Type 2 Diabetes mellitus patients to evaluate safety and efficacy of TQ administration with metformin in a 3-arm study. Patients in arm 1 (T1) received 1 tablet of metformin SR 1000 mg and 1 tablet of TQ 50 mg once daily. The second arm (T2) patients received 1 tablet of metformin SR 1000 mg and 2 tablets of TQ 50 mg once daily. Patients in arm 3 (R) received 1 tablet of metformin SR 1000 mg only.

Results The diabetic mice treated with combination of TQ and metformin showed significant decrease in blood sugar compared to those treated with only metformin. In patients who completed the study, the glycated hemoglobin (HbA1c) values in T1, T2 and R decreased after 3 months from 7.2, 7.2 and 7.3 to 6.7, 6.8, and 7.1, respectively. A greater reduction in Fasting Blood Glucose and Post Prandial Blood Glucose was also observed in T1 and T2 arms compared to R.

Conclusion At dose levels of 50 and 100 mg of TQ combined with a daily dose of 1000 mg Metformin demonstrated a reduction in the levels of HbA1c and blood glucose compared to the standard treatment of diabetic patients with metformin alone.



Publication History

Received: 08 December 2020

Accepted: 31 January 2021

Publication Date:
08 March 2021 (online)

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