Status:
COMPLETED
Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Primary objective: Difference in frequency of subjects with conventionally detected hypoglycemia by the subject \[at least one measurement smaller/equal 60mg/dl documented in the 8-point profile in t...
Eligibility Criteria
Inclusion
- Subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable treatment with NPH insulin(once or twice daily)and mealtime insulin for at least 3 months.
- HbA1c values smaller/equal 8.0%(measured at screening visit, Visit 1).
- Ability and willingness to perform continuous and self monitoring blood glucose profiles, using a self monitoring blood glucose meter as well as carrying the continuous blood glucose meter at least two times for 72 hours throughout the study at home.
Exclusion
- All forms of diabetes other than type 2 diabetes mellitus.
- Oral antidiabetic drugs(OADs)and/or insulins other than NPH and mealtime insulins, except metformin(stable dose for a minimum of 3 months, no dose adjustments during the study).
- Pregnant(as determined by urine pregnancy test at Visit 1)or breast-feeding.
- Women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones or who planned to become pregnant during the study.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. systemic corticosteroids).
- History of hypersensitivity to the study medication or to drugs with similar chemical structures.
- Treatment with any investigational drugs in the last month before study entry.
- History of drug or alcohol abuse.
- Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which required surgical treatment within the study.
- Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
- Known impaired hepatic or renal function.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2004
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00354939
Start Date
October 1 2003
End Date
March 1 2004
Last Update
August 31 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.