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

Status

Status unknown

Phase

Phase 4

Enrollment

938 participants (estimated)

Sponsor

Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders · Other

Design

Not randomized · Open label (no masking)

Countries

1 country

Bangladesh

Start

Sept 2024 (estimated)

Primary completion

Apr 2025 (estimated)

Completion

Jun 2025 (estimated)

First posted

7 Jun 2024

Last update posted

16 Jul 2024

Conditions

Type2diabetes

The study titled "Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh" aims to assess the real-world effectiveness and safety of omarigliptin in managing newly diagnosed type 2 diabetes mellitus (T2DM) patients. Conducted at BIRDEM General Hospital, this 12-month observational study involves 938 patients aged 18 years or older, newly diagnosed with T2DM, with no prior use of antidiabetic medications. T2DM is a growing global health concern, necessitating effective treatment strategies. Omarigliptin, a once-weekly DPP-4 inhibitor, has shown promising results in clinical trials worldwide. However, its real-world efficacy and safety in diverse populations like Bangladesh remain under-explored. This study aims to fill this gap by evaluating omarigliptin in a typical clinical setting in Bangladesh, potentially providing valuable insights for healthcare providers. Study Objectives: To assess the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM. Specific objectives include evaluating glycemic control (HbA1C levels), safety regarding adverse events, and other outcomes such as changes in fasting plasma glucose, electrolyte levels, liver enzymes, creatinine, and lipid profile. Methodology: Conducted in the Department of Endocrinology at BIRDEM General Hospital over 12 months, the study population includes newly diagnosed T2DM patients divided into two groups: those receiving omarigliptin and those receiving other antidiabetic agents. Sample size calculation determined 469 patients per group, accounting for a 15% dropout rate. Inclusion Criteria: * Newly diagnosed T2DM (according to ADA guidelines) aged ≥ 18 years * HbA1C levels between ≥7.0% and ≤10.0% * Stable doses of antidiabetic drugs for at least 4 weeks Exclusion Criteria: * Prescribed insulin for diabetes management * Significant weight loss, hypersensitivity to antidiabetic drugs, type 1 diabetes, ketoacidosis, active liver disease, significant cardiovascular disease, malignancy, hematological disorders, pregnancy, and severe renal impairment, among others. Study Variables: Data will be collected on demographic variables (age, gender, socio-economic status, BMI), laboratory variables (HbA1C, fasting blood glucose, lipid profile, creatinine, electrolytes, ALT, and postprandial glucose), and adverse events (respiratory infections, headaches, gastrointestinal issues, joint pain). Study Procedure: Patients will receive personalized antidiabetic treatment with or without omarigliptin, alongside standard dietary and exercise recommendations. Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment. Data will be collected through interviews, physical exams, and laboratory tests, recorded in case record forms (CRFs). Adverse Event Monitoring: Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. Participants will be instructed to record any side effects in a treatment diary and contact the study team as needed. AEs include any unfavorable medical occurrences, while SAEs involve life-threatening conditions, hospitalization, or significant disability. Data Analysis: Data will be analyzed using SPSS Version 23. Descriptive analyses will investigate participant characteristics, with statistical significance set at p \< 0.05. Parametric variables will be assessed using Student's t-test, and Spearman's correlation will be used for correlations. Regression analyses will also be performed. Ethical Considerations: The study will adhere to the Declaration of Helsinki and other ethical guidelines. Approval will be sought from the Institutional Review Board (IRB) of BIRDEM. Written informed consent will be obtained from all participants before enrollment.

• Experimental

  Omarigliptin

  Arm A will include patients receiving omarigliptin. However, the decision to initiate omarigliptin will be at the treating physician's discretion. The dose of omarigliptin will be 12.5 mg or 25 mg, oral tablet, once weekly decided by the respective physician.

• Active comparator

  Sulphonylureas

  This Arm will include patients receiving Sulphonylureas (Gliclazide/ Glipizide/ Glimepiride/ Tolbutamide) according to the physician's choice.

• Active comparator

  Metformin

  This Arm will include patients receiving Metformin according to the physician's choice.

• Active comparator

  DPP-4i

  This Arm will include patients receiving DPP-4i other than sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin etc.

• Active comparator

  Thiazolidinediones

  This Arm will include patients receiving Thiazolidinediones (Glitazones, pioglitazone, rosiglitazones)

• Active comparator

  Alpha-Glucosidase Inhibitor

  This Arm will include patients receiving Alpha-Glucosidase Inhibitor (Acarbose, Miglitol, etc.)

• Active comparator

  Glucagon-Like Peptide-1

  This Arm will include patients receiving Glucagon-Like Peptide-1

• Active comparator

  Receptor Agonists (GLP1RA)

  This Arm will include patients receiving Exenatide, lixisenatide, liraglutide, albiglutide, dulaglutide, and semaglutide etc.

• Active comparator

  SGLT2 inhibitors

  This Arm will include patients receiving Empagliflozin, Ertugliflozin, Canagliflozin, Dapagliflozin

1. Glycemic Control as Measured by HbA1c Levels

   Time frame · Baseline assessment. Follow-up visits at 14 days, 3 months, and 6 months post-enrollment.

   Registry description

   Evaluation of the efficacy of omarigliptin in managing glycemic control among newly diagnosed Type 2 Diabetes Mellitus (T2DM) patients in a real-world clinical setting.

No study cites this trial.