Status:
COMPLETED
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-74 years
Phase:
PHASE4
Brief Summary
This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.
Eligibility Criteria
Inclusion
- Diabetes Mellitus, Type 2
- have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione \[TZD\]) without insulin, for at least 90 days prior to Visit 1
- glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
- regularly consume a light breakfast (less than 15% of total daily calorie intake)
- capable and willing to follow the protocol
- give written consent
Exclusion
- are taking a TZD whose country label does not allow in combination with insulin
- are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
- have a body mass index greater than 40 kg/m\^2
- have a history of severe hypoglycemia in past 24 weeks
- 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 study medications
- have an irregular sleep/wake cycle
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00664534
Start Date
April 1 2008
End Date
November 1 2010
Last Update
December 13 2011
Active Locations (27)
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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.
Smiths Falls, Ontario, Canada, K7A 4W8
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.
Alexandria, Egypt
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.
Bāb al Lūq, Egypt
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.
Cairo, Egypt, 11562