Study To Know The Use of Trelagliptin Tablets in Diabetes Patients

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus,

• Registration Number: CTRI/2022/10/046634
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This study is a double blind, double dummy, comparative, active-controlled, parallel group, randomized study to evaluate the efficacy and safety of Trelagliptin in Indian 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 in 1:1:1 ratio among the study treatments based on the randomization schedule.

All patients will receive study drug for the duration of 24 weeks. All patients will be followed up for maximum 36 weeks for efficacy and safety assessments. The study is expected to be completed in approximately 2 years after dosing of the first patient.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-17
• Study Start: 2022-10-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Adult male or female patients aged of 18-65 years.
• Patients willing to give written, signed, and dated informed consent to participate in the study.
• Newly diagnosed patients with fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) and 2-h post prandial plasma glucose ≥200 mg/dL (11.1 mmol/L) during oral glucose tolerance test (OGTT) at screening and end of run-in period.
• Patients with Type 2 Diabetes Mellitus and having HbA1C of ≥7% at screening and end of run-in period.
• Females of childbearing potential who are sexually active must agree to use barrier contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
• Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.

Exclusion Criteria

• Patient with Type 1 diabetes mellitus or secondary diabetes.
• 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).
• Patients with history of hypersensitivity reactions with DPP-4 inhibitors.
• Patients received treatment with a PPARγ agent (e.g., pioglitazone or rosiglitazone) or incretin mimetics (e.g., exenatide) within 12 weeks.
• Patients with a body mass index (BMI) < 20 kg/m2 or > 43 kg/m2.
• Patients with history of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications requiring treatment like severe symptomatic orthostatic hypotension, urinary retention, foot ulcers, or gastric stasis.
• Patients with clinically significant renal, hepatic, cerebrovascular, gastrointestinal, cardiovascular, nervous, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders and severe infection.
• Patients with moderate (30 to < 60 ml/min/1.73 m2) to severe (15 to < 30 ml/min/1.73 m2) renal impairment, as determined at Screening, with GFR as calculated by the Cockcroft-Gault formula.
• Patients with history of acute or chronic liver disease, and Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >2.5 X ULN or total bilirubin >1.5 X ULN at the screening period.
• Patients with active heart disease (including acute myocardial infarction, unstable angina within 6 months), 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.
• Patients with history/ current 2nd or 3rd degree atrioventricular block, long QT syndrome or corrected QT interval QTc）>450msec or atrial fibrillation.
• Patients with history of endocrine diseases such as hypercortisolism or polycystic ovary syndrome that may affect blood glucose levels.
• Patients with history of pancreatitis, cholecystitis, gallstones and other digestive diseases.
• Patients undergone weight loss surgery within 3 months before randomization or using weight-loss drugs (including traditional/herbal/ayurvedic/homeopathic) within 2 months.
• randomization 16.
• Patients receiving oral or intravenous use of glucocorticoids or regular application (i.e continuous use more than one week within 4 weeks before randomization) with large doses of thiazide diuretics (hydrochlorothiazide, chlorothiazide, etc.).
• Currently is participating in another investigational study or has participated in an investigational study within 90 days prior to randomization.
• Any other serious disease or condition at screening (or randomization) that would compromise patient safety, might affect life expectancy, or make it difficult to successfully manage and follow the patient according to the protocol.
• Patients with the current/past infections such as HIV, HBV and HCV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change in Glycosylated Haemoglobin (HbA1c) levels.	Day 1 and End of Week 24.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Glycosylated Haemoglobin (HbA1c) levels.	Day 1 and End of Week 12.
The proportion of patients achieving an HbA1C 7%.	End of Week 12 and 24.
Mean Change in Fasting Plasma Glucose (FPG) levels.	Day 1, End of Week 12 and 24.
Mean Change in postprandial plasma glucose (PPG) levels.	Day 1, End of Week 12 and 24.
No of patients requiring rescue therapy.	Week 6, 12 and 24.
Treatment emergent clinical & laboratory adverse events (TEAEs).	Entire Study Period.
Rate of hypoglycemic episodes.	Entire Study Period.

Trial Locations

Locations (5)

ACSR Government Medical College & Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Institute of Post Graduate Medical Education & Research; 🇮🇳 Kolkata, WEST BENGAL, India

Nirmal Hospital; 🇮🇳 Jhansi, UTTAR PRADESH, India

Rajiv Gandhi Institute of Medical Sciences; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

SMS Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

ACSR Government Medical College & Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr SK Noushad Ali

Principal investigator

9494828694

mddbnoal@gmail.com