SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1
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|ClinicalTrials.gov Identifier: NCT00313937|
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : December 7, 2009
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 treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin.
To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Insulin glargine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Centre, Open, Controlled, Randomised (1:1), Parallel Group: Insulin Glargine vs. NPH: FPG (Fasting Plasma Glucose) in Patients With DM Type 1 Who Skip the Morning Meal During Treatment With MDI (Multiple Daily Injection) Basal/Bolus Insulin|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||June 2004|
- Difference of change of blood glucose between patients on Insulin glargine and NPH insulin. [ Time Frame: between 7:00 am and 11:00 am ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313937
|Study Director:||Wolfgang Landgraf, Dr.||Sanofi|