Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-03
Brief Title:
Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh
Sponsor:
Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders
Organization:
Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders
Study Overview
Official Title:
Efficacy and Safety of Omarigliptin A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management Real-World Evaluation in Bangladesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 70 and 100
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 005 Parametric variables will be assessed using Students t-test and Spearmans 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
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 70 and 100
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 005 Parametric variables will be assessed using Students t-test and Spearmans 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
Detailed Description:
IIntroduction Type 2 diabetes mellitus T2DM is a chronic metabolic disorder characterized by insulin resistance and impaired insulin secretion leading to elevated blood glucose levels Associated with significant morbidity and mortality T2DM complications include cardiovascular disease nephropathy retinopathy and neuropathy With its increasing global prevalence especially in developing countries like Bangladesh T2DM poses substantial public health challenges
Management of T2DM requires a combination of lifestyle modifications and pharmacotherapy to achieve and maintain glycemic control Dipeptidyl peptidase-4 DPP-4 inhibitors a class of oral antidiabetic agents enhance the incretin system thereby increasing insulin secretion and decreasing glucagon release in a glucose-dependent manner Omarigliptin a novel once-weekly DPP-4 inhibitor has demonstrated efficacy and safety in clinical trials but its real-world effectiveness and safety profile particularly in diverse populations remain underexplored
Study Objectives The primary objective of this study is to evaluate the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM patients in Bangladesh Specific objectives include assessing glycemic control measured by HbA1c levels monitoring adverse events analyzing changes in fasting plasma glucose FPG postprandial glucose PPG and other laboratory parameters and comparing outcomes with other antidiabetic agents
Methodology
Study Design
This is an observational real-world study conducted over 12 months at the Department of Endocrinology BIRDEM General Hospital Dhaka Bangladesh The study includes newly diagnosed T2DM patients aged 18 years or older Participants are divided into two groups those receiving omarigliptin and those receiving other antidiabetic agents
Study Population
Participants will be newly diagnosed T2DM patients attending BIRDEM General Hospital They will be managed with either omarigliptin or other antidiabetic agents with personalized treatment regimens decided by the attending physician based on clinical conditions
Data Collection
Data will be collected through patient interviews physical examinations and laboratory tests All data will be recorded in standardized case record forms CRFs Follow-up assessments will occur at 14 days 3 months and 6 months post-enrollment
Study Variables
Demographic and laboratory variables will be recorded including age gender socio-economic status BMI HbA1c fasting blood glucose postprandial glucose lipid profile serum creatinine electrolytes and liver enzymes Adverse events will also be tracked and categorized
Study Procedure
Participants will receive personalized antidiabetic treatment including lifestyle modifications and dietary recommendations The treatment regimen including the use of omarigliptin will be determined by the attending physician
Follow-Up Assessments
Follow-up assessments will occur at 14 days 3 months and 6 months post-enrollment During these follow-up visits the following parameters will be checked
14 Days
Review of treatment adherence and any immediate side effects
Physical examination
Fasting plasma glucose FPG levels
Recording any adverse events AEs
3 Months
Physical examination
HbA1c levels
Fasting plasma glucose FPG levels
Postprandial glucose PPG levels
Lipid profile total cholesterol LDL HDL triglycerides
Serum creatinine
Electrolytes
Liver enzymes ALT
Recording any adverse events AEs
6 Months
Comprehensive physical examination
HbA1c levels
Fasting plasma glucose FPG levels
Postprandial glucose PPG levels
Lipid profile total cholesterol LDL HDL triglycerides
Serum creatinine
Electrolytes
Liver enzymes ALT
Monitoring for serious adverse events SAEs
Final recording of adverse events AEs
Adverse Event Monitoring
Adverse events AEs and serious adverse events SAEs will be monitored throughout the study Participants will 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 statistics will summarize patient characteristics Paired t-tests will analyze changes in laboratory parameters Comparisons between groups will be made using Students t-tests and chi-square tests Statistical significance is set at p 005 Regression analysis will identify predictors of treatment response
Ethical Considerations
The study will adhere to the Declaration of Helsinki and relevant local guidelines Ethical approval will be obtained from the Institutional Review Board IRB of BIRDEM Written informed consent will be obtained from all participants before enrollment
Expected Outcomes
The study aims to provide real-world evidence on the efficacy and safety of omarigliptin in a typical clinical setting By comparing outcomes with other antidiabetic agents the study will help elucidate the relative benefits and risks of omarigliptin aiding healthcare providers in making informed treatment decisions
Management of T2DM requires a combination of lifestyle modifications and pharmacotherapy to achieve and maintain glycemic control Dipeptidyl peptidase-4 DPP-4 inhibitors a class of oral antidiabetic agents enhance the incretin system thereby increasing insulin secretion and decreasing glucagon release in a glucose-dependent manner Omarigliptin a novel once-weekly DPP-4 inhibitor has demonstrated efficacy and safety in clinical trials but its real-world effectiveness and safety profile particularly in diverse populations remain underexplored
Study Objectives The primary objective of this study is to evaluate the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM patients in Bangladesh Specific objectives include assessing glycemic control measured by HbA1c levels monitoring adverse events analyzing changes in fasting plasma glucose FPG postprandial glucose PPG and other laboratory parameters and comparing outcomes with other antidiabetic agents
Methodology
Study Design
This is an observational real-world study conducted over 12 months at the Department of Endocrinology BIRDEM General Hospital Dhaka Bangladesh The study includes newly diagnosed T2DM patients aged 18 years or older Participants are divided into two groups those receiving omarigliptin and those receiving other antidiabetic agents
Study Population
Participants will be newly diagnosed T2DM patients attending BIRDEM General Hospital They will be managed with either omarigliptin or other antidiabetic agents with personalized treatment regimens decided by the attending physician based on clinical conditions
Data Collection
Data will be collected through patient interviews physical examinations and laboratory tests All data will be recorded in standardized case record forms CRFs Follow-up assessments will occur at 14 days 3 months and 6 months post-enrollment
Study Variables
Demographic and laboratory variables will be recorded including age gender socio-economic status BMI HbA1c fasting blood glucose postprandial glucose lipid profile serum creatinine electrolytes and liver enzymes Adverse events will also be tracked and categorized
Study Procedure
Participants will receive personalized antidiabetic treatment including lifestyle modifications and dietary recommendations The treatment regimen including the use of omarigliptin will be determined by the attending physician
Follow-Up Assessments
Follow-up assessments will occur at 14 days 3 months and 6 months post-enrollment During these follow-up visits the following parameters will be checked
14 Days
Review of treatment adherence and any immediate side effects
Physical examination
Fasting plasma glucose FPG levels
Recording any adverse events AEs
3 Months
Physical examination
HbA1c levels
Fasting plasma glucose FPG levels
Postprandial glucose PPG levels
Lipid profile total cholesterol LDL HDL triglycerides
Serum creatinine
Electrolytes
Liver enzymes ALT
Recording any adverse events AEs
6 Months
Comprehensive physical examination
HbA1c levels
Fasting plasma glucose FPG levels
Postprandial glucose PPG levels
Lipid profile total cholesterol LDL HDL triglycerides
Serum creatinine
Electrolytes
Liver enzymes ALT
Monitoring for serious adverse events SAEs
Final recording of adverse events AEs
Adverse Event Monitoring
Adverse events AEs and serious adverse events SAEs will be monitored throughout the study Participants will 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 statistics will summarize patient characteristics Paired t-tests will analyze changes in laboratory parameters Comparisons between groups will be made using Students t-tests and chi-square tests Statistical significance is set at p 005 Regression analysis will identify predictors of treatment response
Ethical Considerations
The study will adhere to the Declaration of Helsinki and relevant local guidelines Ethical approval will be obtained from the Institutional Review Board IRB of BIRDEM Written informed consent will be obtained from all participants before enrollment
Expected Outcomes
The study aims to provide real-world evidence on the efficacy and safety of omarigliptin in a typical clinical setting By comparing outcomes with other antidiabetic agents the study will help elucidate the relative benefits and risks of omarigliptin aiding healthcare providers in making informed treatment decisions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BADAS-ERCEC2413 | OTHER | BADAS | None |