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Clinical Trial Details

Trial ID: L5242
Source ID: NCT00191464
Associated Drug: Premeal Insulin Lispro Mixtures
Title: Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: premeal insulin lispro mixtures|DRUG: insulin glargine|DRUG: metformin
Outcome Measures: Primary: HbA1C | Secondary: General inflammation (hsCRP)|High-density lipoprotein cholesterol|Total cholesterol|Triglycerides|Estimates of low-density lipoprotein cholesterol|Nuclear magnetic resonance [NMR] analysis of lipids|Oxidized LDL|Lipoproteins and apoproteins|Fibrinogen|Blood glucose levels (based on self-monitoring)|Insulin dose|Weight|Frequency and incidence of hypoglycemia|Safety|General well-being|Pilot two questionnaires for microvascular complications|Coagulopathy factors [substudy]|Surrogate measure of vascular reactivity [substudy]|Inflammatory markers [substudy]|Production of advanced glycation end-products [substudy]|Generation of oxidative species [substudy]|Lipids in various fractions [substudy]|Retinyl ester measurements in various fractions [substudy]|Composition of triglyceride-rich lipoproteins [substudy]|Compartmental modeling of postprandial lipemia [substudy]|Apolipoproteins [substudy]
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 320
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2003-12
Completion Date: 2005-09
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 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lebanon, New Hampshire, 03756, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., St Leonards, New South Wales, 2065, Australia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Thessaloniki, 56429, Greece|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mumbai, Maharstra, 400 007, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Den Helder, 1783 GZ, Netherlands|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Olesnica, 56-400, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ponce, 00731, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00191464

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details