Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh

Launched by BANGLADESH INSTITUTE OF RESEARCH AND REHABILITATION IN DIABETES, ENDOCRINE AND METABOLIC DISORDERS · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called omarigliptin for people with newly diagnosed type 2 diabetes. Conducted at BIRDEM General Hospital in Bangladesh, the study will follow 938 patients over 12 months to see how well omarigliptin helps manage blood sugar levels and whether it causes any side effects. To qualify for the study, participants must be at least 18 years old, have been recently diagnosed with type 2 diabetes, and have specific blood sugar levels. Those who have used insulin or have certain health conditions will not be eligible.

Participants in the trial will receive either omarigliptin or other diabetes medications, along with guidance on diet and exercise. They will have check-ups at various points throughout the year, where healthcare providers will monitor their health and any side effects they may experience. The study aims to provide important information about how well omarigliptin works in a real-world setting in Bangladesh, which could help doctors manage diabetes more effectively for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed T2DM (according to American Diabetic Association, ADA guideline) aged (≥ 18 years) treated with stable doses of antidiabetic medications (with or without omarigliptin) along with standard diet and exercise
• • HbA1C ranged ≥7.0% and ≤10.0%
• • Stables doses of drug at least 4 weeks
• Exclusion Criteria:
• • Newly diagnosed T2DM who will be prescribed insulin for diabetes management
• • History of significant weight loss in past 6 months (more than or equal to 5 kg in 1 month)
• • Hypersensitivity to any antidiabetic drug
• • Type 1 diabetes, a history of ketoacidosis,
• • Active liver disease,
• • Significant cardiovascular disease,
• • A history of malignancy,
• • Hematological disorders
• • Omarigliptin at any time.
• • Any acute condition (acute coronary syndrome, acute stroke etc.)
• • Pregnancy and lactation
• • eGFR) \<30 mL/min/1.73 m2
• • ALT (alanine aminotransferase)-\>2 times the upper limit of the normal
• • AST (aspartate aminotransferase)-\>2 times the upper limit of the normal
• • TSH-increased or decreased than the normal range
• • Hemoglobin \<11 g/dL (male) or \<10 g/dL (female),
• • Triglycerides \>600 mg/dL, or
• • C-peptide \<0.6 ng/mL