Back to resultsA Study for Patients With Diabetes Mellitus (IOPA) (IOPA)
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Human insulin 30/70
Insulin lispro low mix
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring diabetes, type 1, type 2
Eligibility Criteria
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
Sites / Locations
- 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.
- 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.
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Human insulin mix 30/70
Insulin lispro low mix
Outcomes
Primary Outcome Measures
Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.
Secondary Outcome Measures
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of 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
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
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%
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420095
Brief Title
A Study for Patients With Diabetes Mellitus (IOPA)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
diabetes, type 1, type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Human insulin mix 30/70
Arm Title
2
Arm Type
Experimental
Arm Description
Insulin lispro low mix
Intervention Type
Drug
Intervention Name(s)
Human insulin 30/70
Intervention Description
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin lispro low mix
Other Intervention Name(s)
LM, Low Mix, Humalog
Intervention Description
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Primary Outcome Measure Information:
Title
Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
Description
Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.
Time Frame
Baseline and 12 weeks of each treatment
Secondary Outcome Measure Information:
Title
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment
Description
Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.
Time Frame
Baseline and at 12 weeks of each treatment
Title
Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment
Description
Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint
Time Frame
Baseline and 12 weeks of each treatment
Title
Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment
Description
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
Time Frame
Baseline and 12 weeks of each treatment
Title
Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
Description
Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.
Time Frame
12 weeks of each treatment
Title
Number of Participants With Laboratory Parameters Significantly Different From Baseline
Description
Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.
Time Frame
Baseline and 12 weeks of each treatment
Title
Hypoglycemia Rate Per Participant Per 30 Days
Description
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.
Time Frame
over 12 weeks of each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Guang Zhou
ZIP/Postal Code
510120
Country
China
Facility Name
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.
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
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.
City
Harbin
ZIP/Postal Code
150086
Country
China
Facility Name
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.
City
Hefei
ZIP/Postal Code
230022
Country
China
12. IPD Sharing Statement
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A Study for Patients With Diabetes Mellitus (IOPA)
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