Local Registration Trial in China Humalog Mix 50 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2	Drug: Humalog Mix 50 Drug: Human Insulin Mix 50:50	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

Drug Information available for: Insulin Insulin human Insulin lispro

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

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;


Estimated Enrollment:	120
Study Start Date:	March 2005
Estimated Study Completion Date:	April 2006

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191581

Locations


China
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
Beijing, China
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
Guangzhou, China

Sponsors and Collaborators

Eli Lilly and Company

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00191581 History of Changes
Other Study ID Numbers:	9537 F3Z-MC-IOOR
Study First Received:	September 12, 2005
Last Updated:	July 28, 2006
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases	Immune System Diseases Insulin, Globin Zinc Isophane insulin, insulin lispro drug combination 50:50 Insulin Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016