A clinical study to assess the efficacy and safety of combination of Vildagliptin plus Metformin Tablets in patients with diabetes.

Phase 3

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2021/08/035631
• Lead Sponsor: Synokem Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-04
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 252

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

1. Patients with known hypersensitivity to Vildagliptin.

2. Patients with the history of Type 1 diabetes mellitus.

3. Patients with fasting plasma glucose (FPG) � 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) < 60 mL/min/1.73 m2.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (24 weeks).Timepoint: At Screening/baseline visit, <br/ ><br>Visit 6 [Week 12 / Day 84 (�±2)] and <br/ ><br>Visit 9 [Week 24 / Day 168 (�±2)].