A study of Metformin with / without Administration of Thymoquinone in Patients with Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2018/11/016334
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients of either gender between 18 and 65 years (both inclusive) of age.
2. Patients with type 2 diabetes mellitus.
3. Body mass index (BMI) between 18 kg per meter square to 30 kg per meter square (both inclusive)
4. Patients who are receiving stable dose of metformin 1000 mg per day for last 3
months
5. Patients with HbA1c greater than or equal to 7 percentage and less than or equal to 7.5 percentage.
6. Provides written informed consent and able to comply in accordance with applicable regulatory requirements.
7. Women of child bearing potential must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide,
absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner for at least 4 weeks prior to Study drug administration, during study and up to 30 days after the last dose of Study drug. Male patients must agree to use a male condom throughout the study.
8. Serum pregnancy test at screening and urine pregnancy test at check-in must be negative for women of child bearing potential.
1. Patients taking other oral/injectable antidiabetic agents (e.g. sulfonylurea,
insulin) within last 3 months before screening.
2. Patients on drugs (e.g. steroids, hydroxychloroquine etc) or herbal products
or food (including black cumin seeds) affecting blood glucose within last 3 months prior to screening (exception of ongoing statin therapy / beta blockers in recommended doses that is stable for last 3 months).
3. Patients with drug abuse including narcotics, opioids or any other addictive
substances.
4. Any major organ system disease, chronic cardiac illness (e.g. ischaemic heart disease, heart failure, cardiac arrythmias), chronic liver disease (e.g. hepatic failure, active hepatitis, liver cirrhosis), renal complications and any other chronic debilitating illness.
5. Women of childbearing potential not agreeing to use an effective form of contraception.
6. Known hypersensitivity to Thymoquinone or metformin or any of its ingredients.
7. Creatinine clearance less than or equal to 60 ml/min or known case of renal impairment.
8. Clinically significant laboratory abnormalities at the time of screening.
9. Patients participated in any type of clinical study within the last 30 days of
the screening date.
10. Any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results. Unsuitability for enrollment otherwise as decided by investigator.
11. Patients for whom oral administration of drug is not possible.
12. Treatment with anti-obesity drugs within last 3 months prior to screening or patients who have undergone bariatric surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation and comparision of the efficacy of Tablet Thymoquinone (50 mg and <br/ ><br>100 mg) given concomitantly with Metformin SR 1000 mg tablet against monotherapy of Metformin SR 1000 mg tablet in adult patients with type 2 diabetes mellitus.Timepoint: Day -1 to day 0, Day 15, Day 30, Day 60, Day 90
- Secondary Outcome Measures
Name Time Method Safety of the patients exposed to the Investigational ProductTimepoint: Day -1 to day 0, Day 1, Day 07, Day 15, Day 22, Day 30, Day 37, Day 44, Day 51, Day 60, Day 67, Day 74 and Day 81, Day 90, Day 91