Official Title: “Comparison of HbA1c in Type 1 or Type 2 Diabetic Patients Using Insulin Treated Twice Daily With Either Insulin Lispro Low Mixture or Human Insulin Mix 30/70”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Insulin lispro low mixture
• Drug: Human insulin mix 30/70

Primary Measures

• HbA1c value following 12 weeks of treatment

Secondary Measures

• HbA1c values at baseline, after treatment with insulin lispro low mixture and after treatment with human insulin mix 30/70; HbA1c value change from baseline following treatment with each treatment; Fasting blood glucose values throughout the study

Inclusion Criteria:

• 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 Hb1Ac between 1.2 and 1.7 times the upper limit of normal reference range
• Compliance with diet and insulin therapy and performs regular blood glucose monitoring

Exclusion Criteria:

• Have used oral antidiabetic agents within 30 days prior to entry into the study
• Receive a total daily dose of insulin >2 units/kg
• Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
• Have a body mass index >35 kg/m2
• Receive chronic systemic glucocorticoid therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00420095

Study ID Number: 11423

ClinicalTrials.gov Identifier: NCT00420095

Health Authority: China: State Food and Drug Administration

Lilly Clinical Trial Registry