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

December 4, 2009 updated by: Sanofi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference of change of blood glucose between patients on Insulin glargine and NPH insulin.
Time Frame: between 7:00 am and 11:00 am
between 7:00 am and 11:00 am

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Wolfgang Landgraf, Dr., Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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