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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPIY | Other Identifier | Eli Lilly and Company |
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The main purpose of the study is to investigate whether tirzepatide can be effectively started before Ramadan and used per label in participants with Type 2 Diabetes during the fasting month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR | |
| Number of Hypoglycemic Events | Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Moosa Specialist Hospital | Al Ahasa | 36342 | Saudi Arabia | |||
| National Guard Hospital-King Abdulaziz Medical City |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Number of Self-Reported Gastrointestinal (GI) Adverse Events | Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR |
| Percentage of Participants Achieving HbA1c <7% | Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR |
| Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L) | SoR (Week 0), EoR (Week 4) |
| Alahsa |
| 36428 |
| Saudi Arabia |
| King Abdulaziz Medical City-Jeddah | Jeddah | 21423 | Saudi Arabia |
| King Fahad Armed Forces Hospital Jeddah | Jeddah | 21433 | Saudi Arabia |
| King Faisal Specialist Hospital & Research Center | Jeddah | 21499 | Saudi Arabia |
| Saudi Airlines Medical services | Jeddah | Saudi Arabia |
| King Faisal Specialist Hospital and Research Center Madina | Madinah | 42523 | Saudi Arabia |
| King Saud University | Riyadh | 11472 | Saudi Arabia |
| Osepdale Fatebenefratelli e Oftalmico | Riyadh | 11525 | Saudi Arabia |
| Al Dallah Hospital | Riyadh | 11652 | Saudi Arabia |
| Sulaiman Habib Olaya | Riyadh | 12214 | Saudi Arabia |
| Specialized Medical Center Hospital | Riyadh | 12311 | Saudi Arabia |
| Dallah Namar Hospital | Riyadh | 14963 | Saudi Arabia |
| Dr. Sulaiman Al Habib Hospital As Suwaidi | Riyadh | 14963 | Saudi Arabia |
| Dr. Sulaiman Al Habib Medical Complex Arrayan Saudi Arabia | Riyadh | Saudi Arabia |
| Lifecare Hospital | Abu Dhabi | 133500 | United Arab Emirates |
| Tawam Hospital | Abu Dhabi | 34761 | United Arab Emirates |
| Imperial College London Diabetes Center | Abu Dhabi | United Arab Emirates |
| NMC Abu Dhabi | Abu Dhabi | United Arab Emirates |
| Rashid Centre for Diabetes and Research | Ajman | United Arab Emirates |
| Thumbay University Hospital | Ajman | United Arab Emirates |
| Emirates Hospital Dubai | Dubai | 0000 | United Arab Emirates |
| Aster Clinics | Dubai | United Arab Emirates |
| Dubai Diabetes Center | Dubai | United Arab Emirates |
| Dubai Hospital | Dubai | United Arab Emirates |
| Medcare Hospital | Dubai | United Arab Emirates |
| Mediclinic City Hospital | Dubai | United Arab Emirates |
| Rashid Hospital. | Dubai | United Arab Emirates |
| Medcare Hospital | Sharjah city | 0000 | United Arab Emirates |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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