| Trial ID: | L3501 |
| Source ID: | NCT00420095
|
| Associated Drug: |
Human Insulin 30/70
|
| Title: |
A Study for Patients With Diabetes Mellitus (IOPA)
|
| Acronym: |
IOPA
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00420095/results
|
| Conditions: |
Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Human insulin 30/70|DRUG: Insulin lispro low mix
|
| Outcome Measures: |
Primary: Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint, Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment., Baseline and 12 weeks of each treatment | Secondary: Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment, Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint., Baseline and at 12 weeks of each treatment|Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment, Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint, Baseline and 12 weeks of each treatment|Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment, Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint, Baseline and 12 weeks of each treatment|Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%, Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment., 12 weeks of each treatment|Number of Participants With Laboratory Parameters Significantly Different From Baseline, Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment., Baseline and 12 weeks of each treatment|Hypoglycemia Rate Per Participant Per 30 Days, Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) \* 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment., over 12 weeks of each treatment period
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
117
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-01
|
| Completion Date: |
2008-01
|
| Results First Posted: |
2009-06-05
|
| Last Update Posted: |
2009-06-17
|
| 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., Guang Zhou, 510120, China|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., Hangzhou, 310003, China|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., Harbin, 150086, China|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., Hefei, 230022, China
|
| URL: |
https://clinicaltrials.gov/show/NCT00420095
|
