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SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00313937
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Sanofi

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 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.

Secondary objective:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Difference of change of blood glucose between patients on Insulin glargine and NPH insulin. [ Time Frame: between 7:00 am and 11:00 am ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  • 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.


Information from the National Library of Medicine

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


Locations
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Germany
Sanofi-Aventis
Berlin, Germany
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Wolfgang Landgraf, Dr. Sanofi

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Responsible Party: Heinz Riederer / Medical Director, Sanofi-aventis Germany
ClinicalTrials.gov Identifier: NCT00313937     History of Changes
Other Study ID Numbers: HOE901_4028
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs