Status:
COMPLETED
A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal...
Eligibility Criteria
Inclusion
- Diabetes Mellitus, Type 2
- Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
- Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
- Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\^2
- Capable and willing to follow the protocol
- Give written consent
Exclusion
- Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
- Have a history of severe hypoglycemia in the past 6 months
- Are pregnant or may become pregnant
- Women who are breastfeeding
- Have significant cardiac disease
- Have significant renal or liver disease
- Undergoing therapy for a malignancy
- Contraindications to the study medications
- Have an irregular sleep/wake cycle
- Have a serious disease or any condition considered by the investigator to be exclusionary
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT00666718
Start Date
April 1 2008
End Date
February 1 2010
Last Update
May 13 2011
Active Locations (50)
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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.
Genk, Belgium, 3600
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.
Leuven, Belgium, 3000
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.
Willebroek, Belgium, 2830
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.
Holešov, Czechia, 769 01