| Trial ID: | L5612 |
| Source ID: | NCT05659537
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| Associated Drug: |
Dulaglutide
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| Title: |
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT05659537/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Dulaglutide
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| Outcome Measures: |
Primary: Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths, * An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose. * An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above. * A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record., Baseline through Follow-up (up to 28 weeks)|Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events., Hypoglycemia events were defined as those with blood glucose (BG) levels less than (\<) 70 milligrams per deciliter (mg/dL). Severe hypoglycemia events were defined as those with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. These events could be associated with sufficient neuroglycopenia to induce seizures or coma. The total number of participants who experienced hypoglycemia events, including severe hypoglycemia, was summarized cumulatively., Baseline through Follow-up (up to 28 weeks)|Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24, The percentage of participants who reported AEs and SAEs was calculated by dividing the total number of affected participants by the number of participants analyzed, then multiplying by 100. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record., Baseline through Week 24|Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24, The number of participants who experienced at least one or more GI AEs of nausea, vomiting, and diarrhoea were summarized cumulatively. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record., Baseline through Week 24 | Secondary: Mean Change in HbA1c From Baseline to Week 24, HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The mean change in HbA1c levels was calculated using descriptive analysis, with baseline HbA1c as a covariate. Missing endpoints were addressed using the last observation carried forward (LOCF) method., Baseline, Week 24
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| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
212
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2022-12-29
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| Completion Date: |
2024-01-16
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| Results First Posted: |
2025-02-05
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| Last Update Posted: |
2025-02-20
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| Locations: |
Medlink Hospital Opp Someshwara Jain Temple, Ahmedabad, Ambavadi, 380015, India|Life Care Hospital and Research Centre, Bangalore, Karnataka, 560092, India|Grant Medical Foundation - Ruby Hall Clinic, Pune, Maharashtra, 411001, India|Akshay Hospital, Pune, Maharashtra, 411004, India|Lifepoint Multispecialty Hsptl, Wakad, Pune, 411057, India|Kovai Diabetes Speciality Center and Hospital, Coimbatore, Tamil Nadu, 641009, India|Virinchi Hospital, Hyderabad, Telangana, 50034, India
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| URL: |
https://clinicaltrials.gov/show/NCT05659537
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