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Clinical Trial NCT00322075 for Diabetes Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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SanofiLANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous Phase 4 35
Clinical Trial NCT00322075 was designed to study Treatment for Diabetes Mellitus. This was a Phase 4 interventional study that is now completed. The study started on 1 April 2006, with plans to enroll 35 participants. Led by Sanofi, the expected completion date was 1 November 2006. The latest data from ClinicalTrials.gov was last updated on 12 September 2007.
Brief 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.
Official Title
Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine
Conditions
Diabetes MellitusOther Study IDs
- LANTU_L_00722
- EudraCT # : 2006-000122-31
NCT ID Number
Start Date (Actual)
2006-04
Last Update Posted
2007-09-12
Completion Date (Estimated)
2006-11
Enrollment (Estimated)
35
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | insulin glargine |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
3 days continual glycaemic profile fluctuation | ||
occurrence of adverse events | ||
HbA1c | ||
FBG | ||
BMI | ||
total daily dose of insulin and ratio of doses of basal/prandial insulines | ||
patients´satisfaction |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- Diabetic ketoacidosis
- Any other severe disease
- Pregnancy or fertile female without contraception
- Alcohol/drug abuse, selected prohibited concomitant medication
- Nightshift work
SanofiNo contact data.
1 Study Locations in 1 Countries
Sanofi-Aventis, Prague, Czechia