Clinical trial NCT00420095: A Study for Patients With Diabetes Mellitus (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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: diabetes
type 1
type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
timeFrame: Baseline and 12 weeks of each treatment
Secondary outcomes:
measure: Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment
timeFrame: Baseline and at 12 weeks of each treatment
measure: Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks of each treatment
measure: Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks of each treatment
measure: Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
timeFrame: 12 weeks of each treatment
measure: Number of Participants With Laboratory Parameters Significantly Different From Baseline
timeFrame: Baseline and 12 weeks of each treatment
measure: Hypoglycemia Rate Per Participant Per 30 Days
timeFrame: over 12 weeks of each treatment period
Other outcomes:
Locations:
city: Guang Zhou
country: China
facility: 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
country: China
facility: 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
country: China
facility: 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
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: