Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-04-16 @ 4:47 AM
Study NCT ID:
NCT06449235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587539', 'term': '2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D065089', 'term': 'Glycoside Hydrolase Inhibitors'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 938}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-14', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Control as Measured by HbA1c Levels', 'timeFrame': 'Baseline assessment. Follow-up visits at 14 days, 3 months, and 6 months post-enrollment.', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Omarigliptin', 'Type 2 Diabetes Mellitus', 'DPP-4 inhibitor', 'Real world evidence', 'Bangladesh', 'T2DM'], 'conditions': ['Type2diabetes']}, 'descriptionModule': {'briefSummary': '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.\n\nT2DM 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.\n\nStudy 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.\n\nMethodology: 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.\n\nInclusion Criteria:\n\n* Newly diagnosed T2DM (according to ADA guidelines) aged ≥ 18 years\n* HbA1C levels between ≥7.0% and ≤10.0%\n* Stable doses of antidiabetic drugs for at least 4 weeks\n\nExclusion Criteria:\n\n* Prescribed insulin for diabetes management\n* 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.\n\nStudy 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).\n\nStudy 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).\n\nAdverse 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.\n\nData 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.\n\nEthical 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.', 'detailedDescription': "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.\n\nManagement 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.\n\nStudy 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.\n\nMethodology\n\nStudy Design:\n\nThis 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.\n\nStudy Population:\n\nParticipants 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.\n\nData Collection:\n\nData 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.\n\nStudy Variables:\n\nDemographic 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.\n\nStudy Procedure:\n\nParticipants 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.\n\nFollow-Up Assessments:\n\nFollow-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:\n\n* 14 Days:\n\n * Review of treatment adherence and any immediate side effects\n * Physical examination\n * Fasting plasma glucose (FPG) levels\n * Recording any adverse events (AEs)\n* 3 Months:\n\n * Physical examination\n * HbA1c levels\n * Fasting plasma glucose (FPG) levels\n * Postprandial glucose (PPG) levels\n * Lipid profile (total cholesterol, LDL, HDL, triglycerides)\n * Serum creatinine\n * Electrolytes\n * Liver enzymes (ALT)\n * Recording any adverse events (AEs)\n* 6 Months:\n\n * Comprehensive physical examination\n * HbA1c levels\n * Fasting plasma glucose (FPG) levels\n * Postprandial glucose (PPG) levels\n * Lipid profile (total cholesterol, LDL, HDL, triglycerides)\n * Serum creatinine\n * Electrolytes\n * Liver enzymes (ALT)\n * Monitoring for serious adverse events (SAEs)\n * Final recording of adverse events (AEs)\n\nAdverse Event Monitoring:\n\nAdverse 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.\n\nData Analysis:\n\nData 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 Student's t-tests and chi-square tests. Statistical significance is set at p \\< 0.05. Regression analysis will identify predictors of treatment response.\n\nEthical Considerations:\n\nThe 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.\n\nExpected Outcomes:\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* HbA1C ranged ≥7.0% and ≤10.0%\n* Stables doses of drug at least 4 weeks\n\nExclusion Criteria:\n\n* Newly diagnosed T2DM who will be prescribed insulin for diabetes management\n* History of significant weight loss in past 6 months (more than or equal to 5 kg in 1 month)\n* Hypersensitivity to any antidiabetic drug\n* Type 1 diabetes, a history of ketoacidosis,\n* Active liver disease,\n* Significant cardiovascular disease,\n* A history of malignancy,\n* Hematological disorders\n* Omarigliptin at any time.\n* Any acute condition (acute coronary syndrome, acute stroke etc.)\n* Pregnancy and lactation\n* eGFR) \\<30 mL/min/1.73 m2\n* ALT (alanine aminotransferase)-\\>2 times the upper limit of the normal\n* AST (aspartate aminotransferase)-\\>2 times the upper limit of the normal\n* TSH-increased or decreased than the normal range\n* Hemoglobin \\<11 g/dL (male) or \\<10 g/dL (female),\n* Triglycerides \\>600 mg/dL, or\n* C-peptide \\<0.6 ng/mL'}, 'identificationModule': {'nctId': 'NCT06449235', 'briefTitle': 'Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders'}, 'officialTitle': 'Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh', 'orgStudyIdInfo': {'id': 'BIRDEM'}, 'secondaryIdInfos': [{'id': 'BADAS-ERC/EC/24/13', 'type': 'OTHER', 'domain': 'BADAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omarigliptin', 'description': "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.", 'interventionNames': ['Drug: Omarigliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sulphonylureas', 'description': "This Arm will include patients receiving Sulphonylureas (Gliclazide/ Glipizide/ Glimepiride/ Tolbutamide) according to the physician's choice.", 'interventionNames': ['Drug: Sulphonylureas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': "This Arm will include patients receiving Metformin according to the physician's choice.", 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DPP-4i', 'description': 'This Arm will include patients receiving DPP-4i other than sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin etc.', 'interventionNames': ['Drug: Other DPP4-i']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thiazolidinediones', 'description': 'This Arm will include patients receiving Thiazolidinediones (Glitazones, pioglitazone, rosiglitazones)', 'interventionNames': ['Drug: Thiazolidinediones']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alpha-Glucosidase Inhibitor', 'description': 'This Arm will include patients receiving Alpha-Glucosidase Inhibitor (Acarbose, Miglitol, etc.)', 'interventionNames': ['Drug: Alpha-Glucosidase Inhibitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucagon-Like Peptide-1', 'description': 'This Arm will include patients receiving Glucagon-Like Peptide-1', 'interventionNames': ['Drug: Glucagon-Like Peptide-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Receptor Agonists (GLP1RA)', 'description': 'This Arm will include patients receiving Exenatide, lixisenatide, liraglutide, albiglutide, dulaglutide, and semaglutide etc.', 'interventionNames': ['Drug: Receptor Agonists (GLP1RA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SGLT2 inhibitors', 'description': 'This Arm will include patients receiving Empagliflozin, Ertugliflozin, Canagliflozin, Dapagliflozin', 'interventionNames': ['Drug: SGLT2 inhibitors']}], 'interventions': [{'name': 'Omarigliptin', 'type': 'DRUG', 'description': 'Chemical name: MK-3102 Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor\n\nMechanism of Action:\n\nInhibits 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.', 'armGroupLabels': ['Omarigliptin']}, {'name': 'Sulphonylureas', 'type': 'DRUG', 'description': 'Chemical Name: Sulphonylureas Class: Sulphonylureas\n\nMechanism of Action:\n\nStimulates 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.', 'armGroupLabels': ['Sulphonylureas']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Chemical Name: Metformin Class: Biguanide\n\nMechanism of Action:\n\nDecreases 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.', 'armGroupLabels': ['Metformin']}, {'name': 'Other DPP4-i', 'type': 'DRUG', 'description': 'Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors\n\nMechanism of Action:\n\nInhibits 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.', 'armGroupLabels': ['DPP-4i']}, {'name': 'Thiazolidinediones', 'type': 'DRUG', 'description': 'Chemical Name: Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone) Class: Thiazolidinediones (TZDs)\n\nMechanism of Action:\n\nActivates peroxisome proliferator-activated receptor-gamma (PPAR-γ) in adipose tissue, muscle, and liver.\n\nIncreases 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.', 'armGroupLabels': ['Thiazolidinediones']}, {'name': 'Alpha-Glucosidase Inhibitor', 'type': 'DRUG', 'description': 'Chemical Name: Alpha-Glucosidase Inhibitors (e.g., Acarbose, Miglitol) Class: Alpha-Glucosidase Inhibitors\n\nMechanism of Action:\n\nInhibits 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.', 'armGroupLabels': ['Alpha-Glucosidase Inhibitor']}, {'name': 'Glucagon-Like Peptide-1', 'type': 'DRUG', 'description': 'Chemical Name: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: GLP-1 Receptor Agonists\n\nMechanism of Action:\n\nMimics 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.', 'armGroupLabels': ['Glucagon-Like Peptide-1']}, {'name': 'Receptor Agonists (GLP1RA)', 'type': 'DRUG', 'description': 'Chemical Name: GLP-1 Receptor Agonists (GLP1RA) (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: Glucagon-Like Peptide-1 Receptor Agonists\n\nMechanism of Action:\n\nActivates 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.', 'armGroupLabels': ['Receptor Agonists (GLP1RA)']}, {'name': 'SGLT2 inhibitors', 'type': 'DRUG', 'description': 'Chemical Name: Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin, Ertugliflozin) Class: SGLT2 Inhibitors\n\nMechanism of Action:\n\nInhibits 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.', 'armGroupLabels': ['SGLT2 inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'BIRDEM General Hospital', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Tamanna Tabassum, MBBS, MPH', 'role': 'CONTACT', 'email': 'tamanna.tabassum@pirdc.org', 'phone': '8801755383138'}, {'name': 'Jahid Hasan, MBBS, MPH', 'role': 'CONTACT', 'email': 'dr.jahid61@gmail.com', 'phone': '8801757818973'}], 'overallOfficials': [{'name': 'Faria Afsana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, BIRDEM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pi Research and Development Center', 'class': 'UNKNOWN'}, {'name': 'Acme Laboratories Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department, Department of Endocrinology', 'investigatorFullName': 'Professor Dr. Feroz Amin', 'investigatorAffiliation': 'Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders'}}}}