Status:
COMPLETED
Local Registration Trial in China Humalog Mix 50
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, vers...
Eligibility Criteria
Inclusion
- Men and women who have had either type 1 or type 2 diabetes (World Health Organization\[WHO\]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
- Have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
- Have an HbA1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at Visit 1.
- Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
- Have given informed consent to participate in this study in accordance with local regulations.
Exclusion
- {1\] Have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
- \[2\] Receive a total daily dose of insulin \>2 units/kg.
- \[3\] Have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
- \[4\] Have a body mass index \>35 kg/m2.
- \[5\] Have serum creatinine \> the upper limit of normal (ULN), as determined by a local laboratory.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00191581
Start Date
March 1 2005
End Date
April 1 2006
Last Update
July 31 2006
Active Locations (2)
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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
Beijing, China
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
Guangzhou, China