| Trial ID: | L5624 |
| Source ID: | NCT06370715
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| Associated Drug: |
Insulin Lispro-Aabc
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| Title: |
A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India
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| Acronym: |
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Insulin Lispro-aabc|DRUG: Insulin Glargine
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| Outcome Measures: |
Primary: Percentage of Participants with at least 1 Episode of Hypoglycemia, Percentage of participants with at least 1 episode of hypoglycemia will be reported., Baseline through Week 26 | Secondary: Percentage of Participants with Severe Hypoglycemic Events, Percentage of participants with severe hypoglycemic events defined as (events/participants/year)., Week 26|Percentage of Participants with Nocturnal Hypoglycemia Events, Percentage of participants with nocturnal hypoglycemia events defined as the incidence and rate (events/participant/year) of nocturnal hypoglycemia (BG\<54 mg/dL)., Week 26|Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events, Percentage of participants with nocturnal and documented hypoglycemia events will be reported., Week 26|Change from Baseline to Week 26 in Body Weight, Change from baseline to week 26 in body weight will be reported., Baseline, Week 26|Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score, The ITSQ is a 22-item, participant-completed questionnaire that assesses insulin treatment satisfaction over the past 4 weeks for participants with diabetes in 5 domains: Inconvenience of Regimen (5 items), Lifestyle Flexibility (3 items), Glycemic Control (3 items), Hypoglycemic Control (5 items), Insulin Delivery Device Satisfaction (6 items). Participants respond to each item on a 7-point Likert scale ranging from "not at all" to "extremely." Scores can be generated for each domain and the overall score is transformed to a scale of 0-100. Higher scores indicate better treatment satisfaction., Baseline, Week 26|Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c), Change from baseline to week 26 in HbA1c will be reported., Baseline, Week 26|Percentage of Participants Achieving HbA1c Less Than (<) 7%, Percentage of participants achieving HbA1c \<7% will be reported., Week 26|Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values, 1- and 2-hour PPG values are estimated from self-monitored blood glucose (SMBG), Baseline, Week 26|Change from Baseline to Week 26 in Bolus Insulin Dose, Change from Baseline to Week 26 in Bolus Insulin Dose will be reported., Baseline, Week 26|Change from Baseline to Week 26 in Basal Insulin Dose, Change from Baseline to Week 26 in Basal Insulin Dose will be reported., Baseline, Week 26|Change from Baseline to Week 26 in Bolus Basal: Bolus Ratio, Change from Baseline to Week 26 in Basal: Bolus Ratio will be reported., Baseline, Week 26|Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values, SMBG measurements were taken at 9 time points: fasting, 1 hour post breakfast, 2 hours post breakfast, pre lunch,1 hour post lunch, 2 hours post lunch, pre dinner, 1 hour post dinner, and 2 hours post dinner., Baseline, Week 26
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| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company | Collaborators: Cipla Ltd.
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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: |
112
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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: |
2024-04-18
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| Completion Date: |
2025-10
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| Results First Posted: |
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| Last Update Posted: |
2025-02-25
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| Locations: |
Osmania Medical College & Hospital, Hyderabad, Andhra Pradesh, 500012, India|King George Hospital, Visakhapatnam, Visakhapatnam, Andhra Pradesh, 530002, India|Diabetes Research Centre, Royapuram, Chennai India, 600013, India|Vijyaratna Dibetes Diagnosis Treatment Centre, Ahmedabad, Gujrat, 380007, India|Center for Diabetes and Endocrine Care, Bengaluru, Karnataka, 560043, India|Sahyadri Super Speciality Hospital, Pune, Maharashtra, 411004, India|Chellaram Diabetes Institute, Pune, Maharashtra, 411021, India|S. P. Medical College & A G Hospital, Bikaner, Rajasthan, 334003, India|Rajasthan University of Health Sciences, Jaipur, Rajasthan, 302033, India|Kovai Diabetes Speciality Center and Hospital, Coimbatore, Tamil Nadu, 641009, India|Brij Medical Center Pvt. Ltd., Kanpur, Uttar Pradesh, 208020, India|Medical College & Hospital, Kolkata, Kolkata, West Bengal, 700073, India
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| URL: |
https://clinicaltrials.gov/show/NCT06370715
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