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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Page 1 of 1 (4 locations)

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