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NCT00322075 Clinical Trial

LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

Diabetes Mellitus Clinical Trial

Official title:
Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00322075
Other study ID # LANTU_L_00722
Secondary ID EudraCT # : 2006
Status Completed
Phase Phase 4
First received April 27, 2006
Last updated September 11, 2007
Start date April 2006
Est. completion date November 2006

Study information
Verified date September 2007
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• insulin glargine

Locations
Country Name City State
Czech Republic Sanofi-Aventis Prague

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary 3 days continual glycaemic profile fluctuation
Primary occurrence of adverse events
Primary HbA1c
Primary FBG
Primary BMI
Primary total daily dose of insulin and ratio of doses of basal/prandial insulines
Primary patients´satisfaction
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