Diabetes MellitusPhase 4NCT00322075
LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous
A Phase 4 study testing insulin glargine in people with Diabetes Mellitus, run by Sanofi at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- insulin glargine
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2006to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetic ketoacidosis
- Any other severe disease
- Pregnancy or fertile female without contraception
- Alcohol/drug abuse, selected prohibited concomitant medication
- Nightshift work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine
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.
- Conditions
- Diabetes Mellitus
- Being tested
- insulin glargine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startApr 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zuzana Priborska, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322075
- Sponsor's protocol ID
- LANTU_L_00722
- Other IDs
- EudraCT # : 2006-000122-31
- Status last verified
- Sep 2007
- First submitted
- 27 Apr 2006
- Last updated
- 12 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine
- ClinicalTrials.gov ID
- NCT00322075
- Acronym / sponsor ID
- LANTU_L_00722
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Nov 2006
- First posted
- 4 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Diabetic ketoacidosis
- Any other severe disease
- Pregnancy or fertile female without contraception
- Alcohol/drug abuse, selected prohibited concomitant medication
- Nightshift work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin glargine | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuzana Priborska study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin glargine in people with Diabetes Mellitus, run by Sanofi at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 days continual glycaemic profile fluctuation. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2007.