| Trial ID: | L4005 |
| Source ID: | NCT04153981
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| Associated Drug: |
Insulin Glargine
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| Title: |
A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes 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/NCT04153981/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: Insulin Glargine
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| Outcome Measures: |
Primary: Number or Participants With Hypoglycemic Events, Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) \[≤ 3.0 millimoles per liter (mmol/L)\]., Baseline to Week 24 | Secondary: Basal Insulin Dose, Basal Insulin Dose at Week 24., Week 24|Change From Baseline in Body Weight, Change from baseline in body weight was evaluated. Least Square (LS) mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of the analysis variable as covariate., Baseline, Week 24|Change From Baseline in Hemoglobin A1c (HbA1c), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate., Baseline, Week 12 and Week 24|Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values, Seven-point SMBG was completed at the following timepoints: Before Breakfast, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and at 3 AM (± 1 hour). LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate., Baseline, Week 24|Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ), The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for participants taking insulin, under 5 domains: Inconvenience of Regimen \[(IR) - 5 items\], Lifestyle Flexibility \[(LF) - 3 items\], Glycemic Control \[(GC) - 3 items\], Hypoglycemic Control \[(HC) - 5 items\], Insulin Delivery Device \[(IDD) - 6 items\]. Each Item is measured on a 7-point scale, with scores ranging for IR from 5 to 35, LF from 3 to 21, GC from 3 to 21, HC from 5 to 35, IDD from 6 to 42. Lower scores reflect better outcomes. LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate. ITSQ was not evaluated at Week 0. For this outcome, Week 4 was considered as baseline., Baseline (Week 4), 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: |
304
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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: |
2019-12-16
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| Completion Date: |
2021-07-30
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| Results First Posted: |
2024-02-15
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| Last Update Posted: |
2024-02-15
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| Locations: |
Sir Ganga Ram Hospital, New Delhi, Delhi, 110060, India|DIACARE, Ahemdabad, Gujarat, 380015, India|Gujarat Endocrine Center, Ahmedabad, Gujarat, 380006, India|Nirmal Hospital Private Limited, Surat, Gujarat, 395002, India|Government Medical College & Sir Sayajirao General Hospital, Vadodara, Gujarat, 390001, India|Sumandeep Vidhyapeeth & Dhiraj General Hospital, Vadodara, Gujarat, 391760, India|Bangalore Diabetes Center, Bangalore, Karnataka, 560043, India|Supe Heart & Diabetes Hospital & Research Centre, Nasik, Maharashtra, 422002, India|GSVM Medical College, Kanpur, Uttar Pradesh, 208002, India|Popular Hospital, Varanasi, Uttar Pradesh, 221004, India|Maharaja Agrasen Hospital, New Delhi, 110026, India
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| URL: |
https://clinicaltrials.gov/show/NCT04153981
|
