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: Human insulin 30/70
  • Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
• Drug: Insulin lispro low mix
  • Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Human insulin mix 30/70
• Experimental: 2
  • Insulin lispro low mix

Primary Measures

• Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
  • Time Frame: Baseline and 12 weeks of each treatment
    Safety Issue?: Yes

Secondary Measures

• Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment
  • Time Frame: Baseline and at 12 weeks of each treatment
    Safety Issue?: Yes
• Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment
  • Time Frame: Baseline and 12 weeks of each treatment
    Safety Issue?: Yes
• Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment
  • Time Frame: Baseline and 12 weeks of each treatment
    Safety Issue?: No
• Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
  • Time Frame: 12 weeks of each treatment
    Safety Issue?: Yes
• Number of Participants With Laboratory Parameters Significantly Different From Baseline
  • Time Frame: Baseline and 12 weeks of each treatment
    Safety Issue?: Yes
• Hypoglycemia Rate Per Participant Per 30 Days
  • Time Frame: over 12 weeks of each treatment period
    Safety Issue?: Yes

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 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
• 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/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

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 July 02, 2009

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