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Clinical Trial Details

Trial ID: L4452
Source ID: NCT00447213
Associated Drug: Insulin Glargine
Title: A Study for Patients With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Insulin glargine|DRUG: Human Insulin Inhalation Powder|DRUG: Injectable Insulin
Outcome Measures: Primary: Change in HbA1c from baseline, 12 and 24 weeks | Secondary: Proportion of patients who achieve an HbA1c < 7% and <= 6.5%, 12 and 24 weeks|Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses, at each visit|8-point self monitoring blood glucose profiles, 12 and 24 weeks|Two hour glucose excursions for the morning, midday, and evening meals, 12 and 24 weeks|Inhaler reliability, throughout the study|Patient-reported treatment satisfaction and insulin delivery satisfaction, 12 and 24 weeks|Preference for the study therapies, week 24
Sponsor/Collaborators: Sponsor: Eli Lilly and Company | Collaborators: Alkermes, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-04
Completion Date: 2008-05
Results First Posted:
Last Update Posted: 2010-10-13
Locations: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kanagawa, 235-0045, Japan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo, 160-0023, Japan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Changhua, 500, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Taipei, 104, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tao-Yuan, 333, Taiwan
URL: https://clinicaltrials.gov/show/NCT00447213

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress