NCT Number: NCT00191581
Local Registration Trial in China Humalog Mix 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.
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Human Insulin Mix 50:50
DrugPrimary outcomes
-
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 outcomes
-
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;
Sponsors and collaborators
Lead sponsor
Eli Lilly and Company
Industry
Registry information
Official study 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
Important dates
- Study start
- 2005
- Study completion
- 2006
- First posted
- Sep 19, 2005
- Registry last updated
- Jul 31, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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