24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine
Completed · Phase 4
Conditions studied: Type 2 Diabetes
In brief
The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.
Key facts
- Study ID
- NCT00551538
- Run by
- Eli Lilly and Company
- People needed
- 15
- Starts
- 2003-05-01
- Expected to finish
- 2004-12-01
- Last updated by the study team
- 2010-10-13
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have type 2 diabetes
- Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
- Have used:
- single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
- insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
- a combination of the above.
- Are greater than or equal to 21 and less than 80 years of age
- As determined by the investigator, are capable and willing to:
- comply with their prescribed diet and medication regimen,
- perform self blood glucose monitoring,
- use the patient diary as required for this protocol,
- participate in two 24 hour inpatient assessments
You may not qualify if…
- Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
- Are currently treated with a meglitinide without sulfonylurea
- Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
- Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
- Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1
Where it is running
- 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.