LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-11-30

Brief Summary

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Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year

Exclusion Criteria

* Diabetic ketoacidosis
* Any other severe disease
* Pregnancy or fertile female without contraception
* Alcohol/drug abuse, selected prohibited concomitant medication
* Nightshift work

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Zuzana Priborska

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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EudraCT # : 2006-000122-31

Identifier Type: -

Identifier Source: secondary_id

LANTU_L_00722