A clinical trial to study the efficacy and safety of fixed dose combination of Glimepiride plus Voglibose plus Metformin Tablets in the treatment of type 2 diabetes mellitus.

Phase 4

Completed

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

• Registration Number: CTRI/2021/03/032103
• Lead Sponsor: Inventia Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 355

Inclusion Criteria

1. Male or Female Patients aged between 18 to 65 years (both inclusive).

2. Patients with confirmed documented diagnosis of type 2 diabetes mellitus.

3. Patients, along with diet and exercise control, additionally on treatment with stable daily dose of Metformin 1000 mg for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels between � 8.0 to � 10.0%.

4. Patients with fasting blood glucose � 270 mg/dL at screening visit.

5. Patients with postprandial blood glucose (2 hours post meal) concentration > 200 mg/dL at screening visit.

6. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.

7. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.

8. Patients willing to comply with the protocol requirements.

Exclusion Criteria

1. Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or drugs of similar class.

2. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.

3. Patients with a history of metabolic acidosis or diabetic ketoacidosis.

4. Patients with the Body Mass Index (BMI) < 18.5 and / or > 29.9 kg/m2 at screening visit.

5. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.

6. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.

7. Patients receiving Miconazole.

8. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.

9. Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.

10. Patients with uncontrolled hypertension with sitting systolic BP � 160 mmHg and/or diastolic BP � 100 mmHg at screening.

11. Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patientââ?¬•s participation in the study.

12. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.

13. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.

14. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).

15. Patients with known case of infection with hepatitis B, hepatitis C or HIV.

16. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.

17. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patientââ?¬•s participation in the study.

18. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.

19. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.

20. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.

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: Visit 1 (Baseline / Day -7), Visit 4 (Week 12 / Day 84) and Visit 6 (Week 24 / Day 168).

Secondary Outcome Measures

Name	Time	Method
Changes in clinical laboratory parameters from baseline to end of the study visit (24 weeks).Timepoint: Visit 1 (Baseline / Day -7) and Visit 6 (Week 24 / Day 168).;Mean change in fasting blood glucose (FBG) and 2-hr post prandial blood glucose (2-hr PPBG) from baseline to end of the study visit (24 weeks).Timepoint: Visit 1 (Baseline / Day -7), Visit 3 (Week 6 / Day 42), Visit 4 (Week 12 / Day 84), Visit 5 (Week 18 / Day 126) and Visit 6 (Week 24 / Day 168).;Proportion of patients achieving HbA1c 7.0% at week 12 and week 24.Timepoint: Visit 4 (Week 12 / Day 84) and Visit 6 (Week 24 / Day 168).;Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.Timepoint: Visit 3 (Week 6 / Day 42), Visit 4 (Week 12 / Day 84), Visit 5 (Week 18 / Day 126) and Visit 6 (Week 24 / Day 168).