Status:
COMPLETED
A Study for Patients With Diabetes Mellitus (IOPA)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.
Eligibility Criteria
Inclusion
- Clinically diagnosed type 1or type 2 diabetes for at least 2 months
- Aged between 18 and 70 (inclusive)
- Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
- Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1
- Compliance with diet and insulin therapy and performs regular blood glucose monitoring
Exclusion
- Have used oral antidiabetic agents within 30 days prior to entry into the study
- Receive a total daily dose of insulin \>2 units/kilogram
- Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
- Have a body mass index \>35 kilograms per square meter (kg/m2)
- Receive chronic systemic glucocorticoid therapy
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00420095
Start Date
January 1 2007
End Date
January 1 2008
Last Update
June 17 2009
Active Locations (4)
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1
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.
Guangzhou, China, 510120
2
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, China, 310003
3
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, China, 150086
4
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, China, 230022