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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Insulin glargine
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Difference of change of blood glucose between patients on Insulin glargine and NPH insulin.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2006
Last Updated
December 4, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00313937
Brief Title
SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Primary Outcome Measure Information:
Title
Difference of change of blood glucose between patients on Insulin glargine and NPH insulin.
Time Frame
between 7:00 am and 11:00 am

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Landgraf, Dr.
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Berlin
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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