A Study for Patients With Diabetes Mellitus (IOPA) (IOPA)

June 9, 2009 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guang Zhou, China, 510120
        • 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
        • 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
        • 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
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Human insulin mix 30/70
Drug: Human insulin 30/70
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Experimental: 2
Insulin lispro low mix
Drug: Insulin lispro low mix
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Other Names:
  • Humalog
  • Low Mix
  • LM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
Time Frame: Baseline and 12 weeks of each treatment
Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.
Baseline and 12 weeks of each treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment
Time Frame: 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.
Baseline and at 12 weeks of each treatment
Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks of each treatment
Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint
Baseline and 12 weeks of each treatment
Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment
Time Frame: 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
Baseline and 12 weeks of each treatment
Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
Time Frame: 12 weeks of each treatment
Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.
12 weeks of each treatment
Number of Participants With Laboratory Parameters Significantly Different From Baseline
Time Frame: 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.
Baseline and 12 weeks of each treatment
Hypoglycemia Rate Per Participant Per 30 Days
Time Frame: 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.
over 12 weeks of each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 17, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11423
  • F3Z-GH-IOPA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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