A Study for Patients With Diabetes Mellitus (IOPA)

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: Human insulin 30/70; Drug: Insulin lispro low mix

• Registration Number: NCT00420095
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-09
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-07
• Results First Submitted QC: 2009-04-15
• Status Verified: 2009-06
• Results First Posted: 2009-06-05
• Last Update Submitted: 2009-06-09
• Last Update Posted: 2009-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Human insulin 30/70	Human insulin mix 30/70
2	Insulin lispro low mix	Insulin lispro low mix

Primary Outcome Measures

Name	Time	Method
Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint	Baseline and 12 weeks of each treatment	Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment	Baseline and at 12 weeks of each treatment	Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.
Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment	Baseline and 12 weeks of each treatment	Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint
Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment	Baseline and 12 weeks of each treatment	Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint
Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%	12 weeks of each treatment	Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.
Number of Participants With Laboratory Parameters Significantly Different From Baseline	Baseline and 12 weeks of each treatment	Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.
Hypoglycemia Rate Per Participant Per 30 Days	over 12 weeks of each treatment period	Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) \* 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.

Trial Locations

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.; 🇨🇳 Hefei, China