| Trial ID: | L6027 |
| Source ID: | NCT00551538
|
| Associated Drug: |
Lispro Mix 75/25
|
| Title: |
24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Lispro mix 75/25|DRUG: Glargine
|
| Outcome Measures: |
Primary: Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period., At end of treatment arm or 3 months. | Secondary: HbA1c, At end of treatment arm or 3 months.|2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined, At end of treatment arm or 3 months.|Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL), At end of treatment arm or 3 months.|The number of patients with increased plasma glucose during the last 2 hours of each inpatient period, At end of treatment arm or 3 months.|The mean amplitude of glycemic excursion, At end of treatment arm or 3 months.|Concentration of plasma triglycerides and free fatty acids, At end of treatment arm or 3 months.|Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value, At end of treatment arm or 3 months.|Insulin dose and body weight, At end of treatment arm or 3 months.
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-05
|
| Completion Date: |
2004-12
|
| 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Indianapolis, Indiana, 46202, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00551538
|
