Local Registration Trial in China Humalog Mix 50
Study Details
Study Description
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, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50 []
Secondary Outcome Measures
- The secondary objectives of the study are: []
- Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50. []
- Assess HbA1c values at baseline and after treatment with human insulin mix 50/50. []
- To compare human insulin mix 50/50 with insulin lispro mix 50/50 with regard to []
- Effects on HbA1c values obtained at the end of each treatment period; []
- Effects on fasting blood glucose values obtained throughout the study; []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
{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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9537
- F3Z-MC-IOOR