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Local Registration Trial in China Humalog Mix 50

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Humalog Mix 50
Human Insulin Mix 50:50
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women who have had either type 1 or type 2 diabetes (World Health Organization[WHO]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent. Have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study. Have an HbA1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at Visit 1. Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring. Have given informed consent to participate in this study in accordance with local regulations. Exclusion Criteria: {1] Have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study. [2] Receive a total daily dose of insulin >2 units/kg. [3] Have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study. [4] Have a body mass index >35 kg/m2. [5] Have serum creatinine > the upper limit of normal (ULN), as determined by a local laboratory.

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

Outcomes

Primary Outcome Measures

The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50

Secondary Outcome Measures

The secondary objectives of the study are:
Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50.
Assess HbA1c values at baseline and after treatment with human insulin mix 50/50.
To compare human insulin mix 50/50 with insulin lispro mix 50/50 with regard to
Effects on HbA1c values obtained at the end of each treatment period;
Effects on fasting blood glucose values obtained throughout the study;

Full Information

First Posted
September 12, 2005
Last Updated
July 28, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00191581
Brief Title
Local Registration Trial in China Humalog Mix 50
Official Title
Comparison of 2-Hour Postprandial Blood Glucose Excursion in Response to a Standard Test Meal in Insulin-Requiring Diabetic Patients Treated Twice Daily With Either Insulin Lispro Mix 50/50 or Human Insulin Mix 50/50
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Humalog Mix 50
Intervention Type
Drug
Intervention Name(s)
Human Insulin Mix 50:50
Primary Outcome Measure Information:
Title
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50
Secondary Outcome Measure Information:
Title
The secondary objectives of the study are:
Title
Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50.
Title
Assess HbA1c values at baseline and after treatment with human insulin mix 50/50.
Title
To compare human insulin mix 50/50 with insulin lispro mix 50/50 with regard to
Title
Effects on HbA1c values obtained at the end of each treatment period;
Title
Effects on fasting blood glucose values obtained throughout the study;

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: Men and women who have had either type 1 or type 2 diabetes (World Health Organization[WHO]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent. Have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study. Have an HbA1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at Visit 1. Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring. Have given informed consent to participate in this study in accordance with local regulations. Exclusion Criteria: {1] Have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study. [2] Receive a total daily dose of insulin >2 units/kg. [3] Have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study. [4] Have a body mass index >35 kg/m2. [5] Have serum creatinine > the upper limit of normal (ULN), as determined by a local laboratory.
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 - 5 PM 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
Beijing
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
Guangzhou
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
18657196
Citation
Gao Y, Li G, Li Y, Guo X, Yuan G, Gong Q, Yan L, Zheng Y, Zhang J. Postprandial blood glucose response to a standard test meal in insulin-requiring patients with diabetes treated with insulin lispro mix 50 or human insulin mix 50. Int J Clin Pract. 2008 Sep;62(9):1344-51. doi: 10.1111/j.1742-1241.2008.01850.x. Epub 2008 Jul 24.
Results Reference
derived

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Local Registration Trial in China Humalog Mix 50

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