Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Arm 1 (T1): Tablet Metformin SR 1000 mg and Tablet thymoquinone 12.5 mg: Dose: 1000 mg and 12.5 mg, Route of administration: Oral,Frequency: Once daily, Duration: 90 days
Intervention2:
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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/m2 to 30 kg/m2 (both inclusive) 4. Patients who are receiving stable dose of metformin 1000 mg/day for last 3 months 5. Patients with HbA1c greater than or equal to 7.0 percentage and less than or equal to 7.5 percentage. 6. Provides written informed consent 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 (WOCBP).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in HbA1c from baseline to EOSTimepoint: On Day 1, Day 30, Day 60 and Day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportions of patients achieving HbA1c 7 % at EOS 2. Change in fasting blood glucose (FBG) from baseline to EOS 3. Change in post prandial blood glucose (PPBG) from baseline to EOS 4. Change in body weight from baseline to EOS 5. Change in the non-HDL cholesterol levels (total cholesterol â?? HDL levels) from baseline to EOS Safety Evaluation -Number of episodes of hypoglycemia in each arm from baseline to EOS - Incidence of adverse events and serious adverse events in each armTimepoint: 1. On Day 1, 30, 60 and 91 2. & 3. On Day 1, 15, 30, 60 and 91 4. On Day 1, 7, 15, 30, 60 and 91 5. On Day 1, 30, 60 and 91 | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd.
Outcome results
None listed