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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Insulin glargine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Sanofi-aventis Germany

Principal Investigators

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Wolfgang Landgraf, Dr.

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HOE901_4028

Identifier Type: -

Identifier Source: org_study_id