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Local Registration Trial in China Humalog Mix 50
This study has been completed.
Study NCT00191581   Information provided by Eli Lilly and Company
First Received: September 12, 2005   Last Updated: July 28, 2006   History of Changes

September 12, 2005
July 28, 2006
March 2005
 
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
Same as current
Complete list of historical versions of study NCT00191581 on ClinicalTrials.gov Archive Site
  • 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;
  • 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;
 
Local Registration Trial in China Humalog Mix 50
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

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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Drug: Humalog Mix 50
  • Drug: Human Insulin Mix 50:50
 
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. Epub 2008 Jul 24.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
April 2006
 

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
  5. 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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00191581
 
9537, F3Z-MC-IOOR
Eli Lilly and Company
 
Study Director: 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 Eli Lilly and Company
Eli Lilly and Company
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP