Status:
COMPLETED
A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration t...
Detailed Description
A multicenter, non-randomized, open-label, post-marketing clinical study. The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs. T...
Eligibility Criteria
Inclusion
- Patients diagnosed as having type 2 Diabetes.
- Patients who have not been on insulin treatment within 6 months.
- Patients who have been taking OADs for at least 90 days.
- Patients with an HbA1c level in the range of 7.5% to 11.0%.
- Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.
Exclusion
- Patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
- Patients having or suspected of having malignancy
- Patients having serious complications of the heart, liver, or kidney.
- Patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
- Patients receiving systemic steroids.
- Are currently enrolled in a clinical trial of a non-approved drug. Or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
- Patients of child-bearing potential. Breastfeeding patients. Patients with a positive result in a pregnancy test performed for women of child-bearing potential.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00971997
Start Date
September 1 2009
End Date
April 1 2011
Last Update
April 11 2012
Active Locations (14)
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1
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.
Aichi, Japan, 455-8530
2
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.
Chiba, Japan, 277-0832
3
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.
Fukuoka, Japan, 807-0856
4
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.
Hiroshima, Japan, 738-8503