Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Vildagliptin SR 100 mg plus Metformin SR 500 mg Tablets & Placebo Tablets: Patients will be advised to take one tablet twice daily orally, swallowed as a whole with water in the
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female Patients aged between 18 to 65 years (both inclusive). 2. Patients with Type 2 Diabetes Mellitus who have been treated with upto 1 gram per day of Metformin monotherapy for at least 3 months prior to screening and having inadequate glycemic control [Glycosylated Hemoglobin (HbA1c) levels of > 7% to � 9%]. 3. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 4. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to Vildagliptin. 2. Patients with the history of Type 1 diabetes mellitus. 3. Patients with fasting plasma glucose (FPG) ââ?°Â¥ 200 mg/dl and/or glycosylated hemoglobin (HbA1c) >9%. 4. Patients who are accepting treatments of arrhythmias. 5.Patients with known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy. 6. Patients with known history of acute or chronic pancreatitis. 7. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL]. 8. Patients with estimated glomerular filtration rate (eGFR) 9. Patients with a history of New York Heart Association (NYHA) Class III or IV heart failure. 10. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, gastric dysfunction, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infections, that may affect patient safety or difficult to evaluate the efficacy of the product. 11. Patients receiving treatment with systemic corticosteroids. 12. Patients with history of HIV and /or Hepatitis B and /or Hepatitis C. 13. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 14. Females who are not ready to use acceptable contraceptive methods during the course of study. 15. Patients with the history of alcohol or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to screening. 16. Patients with medical history of Oncological Conditions since last 5 years. 17. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 18. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 19. Suspected inability or unwillingness to comply with the study procedures. 20. Any other condition that in the opinion of the Investigator that does not justify the patientââ?¬•s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (24 weeks).Timepoint: At Screening/baseline visit, Visit 6 [Week 12 / Day 84 (Ã?±2)] and Visit 9 [Week 24 / Day 168 (Ã?±2)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (24 weeks).Timepoint: At Screening/baseline visit, Visit 3 [Week 2 / Day 14 (Ã?±2)], Visit 4 [Week 4 / Day 28 (Ã?±2)], Visit 5 [Week 8 / Day 56 (Ã?±2)], Visit 6 [Week 12 / Day 84 (Ã?±2)], Visit 7 [Week 16 / Day 112 (Ã?±2)], Visit 8 [Week 20 / Day 140 (Ã?±2)] and Visit 9 [Week 24 / Day 168 (Ã?±2)].;Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (24 weeks).Timepoint: At Screening/baseline visit, Visit 3 [Week 2 / Day 14 (Ã?±2)], Visit 4 [Week 4 / Day 28 (Ã?±2)], Visit 5 [Week 8 / Day 56 (Ã?±2)], Visit 6 [Week 12 / Day 84 (Ã?±2)], Visit 7 [Week 16 / Day 112 (Ã?±2)], Visit 8 [Week 20 / Day 140 (Ã?±2)] and Visit 9 [Week 24 / Day 168 (Ã?±2)].;Adverse events / serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study visit (24 weeks).Timepoint: At Screening/baseline visit, Visit 6 [Week 12 / Day 84 (Ã?±2)] and Visit 9 [Week 24 / Day 168 (Ã?±2)].;Hypoglycemic episodes during the study.Timepoint: Throughout the study. | — |
Countries
India
Contacts
Public ContactSurender Kumar Arora
Clinwave Research Pvt. Ltd.
Outcome results
None listed