A Study for Patients With Diabetes Mellitus (IOPA)

Diabetes Mellitus, Type 2 Clinical Trial

— IOPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420095
• Other study ID #: 11423
• Secondary ID: F3Z-GH-IOPA
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2007
• Last updated: June 9, 2009
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: June 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 1

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
China	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.	Guang Zhou
China	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint		Baseline and 12 weeks of each treatment	Yes
Secondary	Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment		Baseline and at 12 weeks of each treatment	Yes
Secondary	Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment		Baseline and 12 weeks of each treatment	Yes
Secondary	Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment		Baseline and 12 weeks of each treatment	No
Secondary	Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%		12 weeks of each treatment	Yes
Secondary	Number of Participants With Laboratory Parameters Significantly Different From Baseline		Baseline and 12 weeks of each treatment	Yes
Secondary	Hypoglycemia Rate Per Participant Per 30 Days		over 12 weeks of each treatment period	Yes

External Links

•   Lilly Clinical Trial Registry