Status:
COMPLETED
SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary objective: To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during trea...
Eligibility Criteria
Inclusion
- Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l).
Exclusion
- Breast-feeding
- History of hypersensitivity to the study medication or to drugs with similar chemical structures
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
- Treatment with any investigational drug in the last 30 days before study entry
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- History of drug or alcohol abuse
- No subjects who have previously been treated with Insulin glargine will be enrolled in this study.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00313937
Start Date
November 1 2001
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Berlin, Germany