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

NCT06449235 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: BIRDEMBADAS-ERC/EC/24/13
• Study Type: interventional
• Target: 938
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2diabetes

Keywords

Omarigliptin; Type 2 Diabetes Mellitus; DPP-4 inhibitor; Real world evidence; Bangladesh; T2DM

Outcome Measures

Primary Outcomes (1)

• Glycemic Control as Measured by HbA1c Levels

  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.

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

Study Arms (9)

Omarigliptin

EXPERIMENTAL

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.

Drug: Omarigliptin

Sulphonylureas

ACTIVE COMPARATOR

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

Drug: Sulphonylureas

Metformin

ACTIVE COMPARATOR

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

Drug: Metformin

DPP-4i

ACTIVE COMPARATOR

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

Drug: Other DPP4-i

Thiazolidinediones

ACTIVE COMPARATOR

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

Drug: Thiazolidinediones

Alpha-Glucosidase Inhibitor

ACTIVE COMPARATOR

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

Drug: Alpha-Glucosidase Inhibitor

Glucagon-Like Peptide-1

ACTIVE COMPARATOR

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

Drug: Glucagon-Like Peptide-1

Receptor Agonists (GLP1RA)

ACTIVE COMPARATOR

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

Drug: Receptor Agonists (GLP1RA)

SGLT2 inhibitors

ACTIVE COMPARATOR

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

Drug: SGLT2 inhibitors

Interventions

Omarigliptin DRUG

Chemical name: MK-3102 Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor Mechanism of Action: Inhibits DPP-4 enzyme, thereby increasing incretin levels. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Improves β-cell function of the pancreas. Reduces hepatic glucose output. Administration: Once-weekly oral dosing.

Omarigliptin

Sulphonylureas DRUG

Chemical Name: Sulphonylureas Class: Sulphonylureas Mechanism of Action: Stimulates insulin release from pancreatic beta cells. Enhances the sensitivity of beta cells to glucose. Reduces hepatic glucose production. Increases peripheral glucose uptake and utilization. Administration: Typically administered once or twice daily, depending on the specific medication and patient needs.

Sulphonylureas

Metformin DRUG

Chemical Name: Metformin Class: Biguanide Mechanism of Action: Decreases hepatic glucose production. Improves insulin sensitivity in peripheral tissues. Enhances peripheral glucose uptake and utilization. Reduces intestinal absorption of glucose. Administration: Administered orally, usually once or twice daily with meals.

Metformin

Other DPP4-i DRUG

Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Mechanism of Action: Inhibits DPP-4 enzyme, thereby increasing incretin levels. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Improves β-cell function of the pancreas. Reduces hepatic glucose output. Administration: Typically administered orally once daily. Dosage may vary depending on the specific medication and patient needs.

DPP-4i

Thiazolidinediones DRUG

Chemical Name: Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone) Class: Thiazolidinediones (TZDs) Mechanism of Action: Activates peroxisome proliferator-activated receptor-gamma (PPAR-γ) in adipose tissue, muscle, and liver. Increases insulin sensitivity in peripheral tissues. Enhances glucose uptake and utilization in muscle and adipose tissue. Reduces hepatic glucose production. Administration: Administered orally, typically once daily. Dosage may vary based on the specific medication and patient response.

Thiazolidinediones

Alpha-Glucosidase Inhibitor DRUG

Chemical Name: Alpha-Glucosidase Inhibitors (e.g., Acarbose, Miglitol) Class: Alpha-Glucosidase Inhibitors Mechanism of Action: Inhibits alpha-glucosidase enzymes in the small intestine. Delays the breakdown and absorption of complex carbohydrates. Reduces postprandial blood glucose levels. Administration: Administered orally, typically taken with the first bite of each main meal. Dosage may vary based on the specific medication and patient response.

Alpha-Glucosidase Inhibitor

Glucagon-Like Peptide-1 DRUG

Chemical Name: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: GLP-1 Receptor Agonists Mechanism of Action: Mimics the action of endogenous GLP-1. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Slows gastric emptying. Promotes satiety and reduces food intake. Improves β-cell function of the pancreas. Administration: Administered via subcutaneous injection, with frequency varying from twice daily to once weekly, depending on the specific medication.

Glucagon-Like Peptide-1

Receptor Agonists (GLP1RA) DRUG

Chemical Name: GLP-1 Receptor Agonists (GLP1RA) (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: Glucagon-Like Peptide-1 Receptor Agonists Mechanism of Action: Activates GLP-1 receptors. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Slows gastric emptying. Promotes satiety and reduces food intake. Improves β-cell function of the pancreas. Administration: Administered via subcutaneous injection, with frequency varying from twice daily to once weekly, depending on the specific medication.

Receptor Agonists (GLP1RA)

SGLT2 inhibitors DRUG

Chemical Name: Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin, Ertugliflozin) Class: SGLT2 Inhibitors Mechanism of Action: Inhibits SGLT2 in the proximal renal tubules. Reduces reabsorption of filtered glucose from the renal tubules. Increases urinary glucose excretion. Lowers blood glucose levels independently of insulin. Administration: Administered orally, typically once daily. Dosage may vary based on the specific medication and patient response.

SGLT2 inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders: lead
• Pi Research and Development Center: collaborator
• Acme Laboratories Ltd.: collaborator

Study Sites (1)

BIRDEM General Hospital

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine; Sulfonylurea Compounds; Metformin; Thiazolidinediones; Glycoside Hydrolase Inhibitors; Glucagon-Like Peptide 1; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Faria Afsana, MD

  Associate Professor, BIRDEM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamanna Tabassum, MBBS, MPH

CONTACT

8801755383138; tamanna.tabassum@pirdc.org

Jahid Hasan, MBBS, MPH

CONTACT

8801757818973; dr.jahid61@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department, Department of Endocrinology

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

BA (1)