Study to Know the Use of Metformin ER, Glimepiride and Voglibose combination in Diabetes Mellitus

Phase 4

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2022/05/042922
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This study is an Open Label, Multi-Center, Parallel, Three Arm, Comparative Clinical Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Metformin ER, Glimepiride and Voglibose tablets in Adult Patients with Type 2 Diabetes Mellitus. Patients will be screened for study eligibility based on the inclusion and exclusion criteria.



Patients eligible for the study will be randomized to either FDC of Metformin hydrochloride ER 500mg + Glimepiride 1/2mg + Voglibose 0.2mg or FDC of Metformin hydrochloride ER 500mg + Voglibose 0.2/0.3mg or FDC Metformin hydrochloride ER 500mg+ Glimepiride 1/2mg based on the randomization schedule. All patients will receive study drug twice daily, orally before major meals for the duration of 24 weeks. All patients will be followed up for 24 weeks for efficacy and safety assessments. The study is expected to be completed in approximately 12 months after dosing of the first patient.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-05-27
• Study Start: 2022-05-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

• 1.Adult male or female patients aged of 18-65 years and willing to give written, signed, and dated informed consent to participate in the study.
• 2.Patients who are on metformin ≥1500mg/day and <2550mg/day at the time of screening.
• 3.Fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) and HbA1C of 8%–11% at screening and end of run-in period.
• 4.Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
• 5.Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range of the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.

Exclusion Criteria

• 1.Patient with Type 1 diabetes mellitus or secondary diabetes.
• 2.Patients with known hypersensitivity to any of the components of the study drugs.
• 3.Patients with fasting plasma glucose ≥250 mg/dL or ≥13.9mmol/L or a history of severe hypoglycemia (blood sugar ≤50 mg/dL or ≤2.8mmol/L).
• 4.Patients received insulin within 8 weeks prior to screening or Patients requiring insulin therapy or already on insulin therapy.
• 5.Patients received treatment with a PPARγ agent (e.g., pioglitazone or rosiglitazone) or incretin mimetics (e.g., exenatide) within 12 weeks.
• 6.Patients receiving treatment with systemic corticosteroids.
• 7.Patients with a body mass index (BMI) < 20 kg/m2 or > 43 kg/m2.
• 8.Patients with renal disease or renal dysfunction (creatinine clearance i.e. eGFR <30 ml/min/1.73 m2).
• 9.Patients planned for intravascular contrast studies with iodinated materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials) during the study period.
• 10.Patients with history of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.
• 11.Patients with active heart disease (including acute myocardial infarction, unstable angina within 6 months), moderate to severe congestive heart failure (NYHA class III or IV), percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attacks.
• 12.Patients with history of acute or chronic liver disease with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >2.5 times of upper limit of normal reference range or total bilirubin >1.5 times of upper limit of normal reference range during the screening period.
• 13.Patients with history of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, foot ulcers, or gastric stasis.
• 14.Patients with clinically significant renal, hepatic, cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infection.
• 15.Patients with the current/past infections such as Hepatitis B/C, and/or patients with immune system disorders like HIV.
• 16.Required to take or continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
• 17.History of drug or alcohol abuse within the past 2 years.
• 18.Currently is participating in another investigational study or has participated in an investigational study within 90 days prior to randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the glycated hemoglobin (HbA1c)	At Day 1 and At Week 24

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving an HbA1C 7%	At Week 24
Change in the postprandial plasma glucose (PPG)	At Day 1 and At Week 24
Change in the fasting plasma glucose (FPG)	At Day 1 and At Week 24
No of patients requiring rescue therapy	Throughout the study period
Rate of hypoglycemic episodes (severe hypoglycemia, documented symptomatic hypoglycemia and asymptomatic hypoglycemia)	Throughout the study period
Incidence treatment emergent clinical, laboratory adverse events (TEAEs) including hypoglycaemic episodes	Throughout the study period

Trial Locations

Locations (3)

Government Medical College & Govt. General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Nirmal Hospital; 🇮🇳 Jhansi, UTTAR PRADESH, India

SMS Medical College& Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Government Medical College & Govt. General Hospital (Old RIMSGGH)

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr A Gopal Rao

Principal investigator

9440122790

drgopalraoa@gmail.com