Local Registration Trial in China Humalog Mix 50
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ClinicalTrials.gov Identifier: NCT00191581 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : July 31, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 | Drug: Humalog Mix 50 Drug: Human Insulin Mix 50:50 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | March 2005 |
Study Completion Date : | April 2006 |

- 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
- 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;

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191581
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 |
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 |
ClinicalTrials.gov Identifier: | NCT00191581 |
Other Study ID Numbers: |
9537 F3Z-MC-IOOR |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | July 31, 2006 |
Last Verified: | July 2006 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Insulin Lispro Insulin, Globin Zinc Isophane insulin, insulin lispro drug combination 50:50 Hypoglycemic Agents Physiological Effects of Drugs |