Diabetes Mellitus, Type 2NCT00423215
LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Israel.
Trial summary
The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glargine (LANTUS)
- Type of treatment
- Injection or infusion
- How many people
- 1,007 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to May 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type II Diabetes
Who may be able to join
- Patients with type 2 diabetes mellitus,
- Having been treated with any other insulin, but who did not reach the target of A1c=7%.
- Ability and willingness to perform Self Monitoring Blood Glucose measurement
Who cannot join
- Will follow the prescribing information (Summary of Product Characteristics).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Therapeutic Observational Evaluation of the Efficacy and Safety Profile of Lantus in Everyday Medical Practice in Type 2 Diabetes Mellitus Patients, Who Start Receiving Lantus - Treated With Any Other Insulin, With A1c>7%
The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glargine (LANTUS)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargine (LANTUS)Drug
The patients will receive Lantus administered by subcutaneous injection, once daily at any time but at the same time each day.
Treatment duration: 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type II diabetes | Not described Receives: Drug: Insulin glargine (LANTUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Glycolysated Haemoglobin (HbA1c) level reduction
Measured: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)
Secondary outcomes (4)
Measure of Fasting Blood Glucose (FBG) level reduction
Measured: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)
Investigator assessment
Measured: At the end of the study (i.e. 4 months +/- 2 weeks)
Insulin dose
Measured: At the end of the study (i.e. 4 months +/- 2 weeks)
Patient's satisfaction
Measured: At the end of the study (i.e. 4 months +/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startMar 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nurit Tweezer-Zaks, M.D., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423215
- Sponsor's protocol ID
- HOE901_5062
- Status last verified
- Jun 2009
- First submitted
- 17 Jan 2007
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Therapeutic Observational Evaluation of the Efficacy and Safety Profile of Lantus in Everyday Medical Practice in Type 2 Diabetes Mellitus Patients, Who Start Receiving Lantus - Treated With Any Other Insulin, With A1c>7%
- ClinicalTrials.gov ID
- NCT00423215
- Acronym / sponsor ID
- HOE901_5062
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Jan 2007 (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.
The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type II diabetes | – | Drug: Insulin glargine (LANTUS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type II Diabetes
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus,
- Having been treated with any other insulin, but who did not reach the target of A1c=7%.
- Ability and willingness to perform Self Monitoring Blood Glucose measurement
Key exclusion criteria (2 listed)
- Will follow the prescribing information (Summary of Product Characteristics).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 (LANTUS)The patients will receive Lantus administered by subcutaneous injection, once daily at any time but at the same time each day. Treatment duration: 4 months. | Drug | Patients with Type II diabetes |
Primary outcome
Measure of Glycolysated Haemoglobin (HbA1c) level reduction
Time frame: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)
4 secondary outcomes
Measure of Fasting Blood Glucose (FBG) level reduction
Time frame: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)
Investigator assessment
Time frame: At the end of the study (i.e. 4 months +/- 2 weeks)
Insulin dose
Time frame: At the end of the study (i.e. 4 months +/- 2 weeks)
Patient's satisfaction
Time frame: At the end of the study (i.e. 4 months +/- 2 weeks)
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 15 Jun 2009.
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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.
Nurit Tweezer-Zaks, M.D. study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Israel.
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 3 inclusion and 2 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 15 Jun 2009. 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 Israel. 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.
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?
Measure of Glycolysated Haemoglobin (HbA1c) level reduction (time frame: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)). 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 15 Jun 2009.