Diabetes Mellitus, Type 2Phase 4NCT00174681
Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
A Phase 4 study testing Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 6 sites in 6 countries.
Trial summary
Primary objective: The primary objective of this trial is: To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine
- How many people
- 390 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Apr 2003to not given
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects fulfilling all of the following criteria will be eligible for inclusion in the trial:
- Type 2 diabetes
- 24 ≤ BMI ≤ 35 kg/m2
- 7 % ≤ HbA1c ≤ 8 %
- Treated with OAD for at least 2 years
- Treated with at least two oral antidiabetics including one sulphonylurea at the maximum tolerated dosages and metformin at the maximum tolerated dosages
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- Not treated with a glinide or thiazolidinedione.
- Capable of performing blood glucose self-monitoring and a self-injection of insulin.
- Funduscopy within the previous year at the time of inclusion.
Who cannot join
- Patient with any of the following criteria will not be included in the trial:
- Type 1 diabetics
- Insulin-treated type 2 diabetics or having previously received long-term insulin, or treated with a thiazolidinedione or glinide
- Fasting blood glucose < 1.20 g/l.
- Pregnancy (non-menopausal women must have a pregnancy test before the inclusion visit and effective contraception).
- Lactation.
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- History of hypersensitivity to the investigational product or to drugs with similar chemical structures.
- Systemic treatment with corticosteroids irrespective of the dose and irrespective of the previous or anticipated duration of treatment.
- Treatment with another product under development in the 2 months preceding the date of inclusion in the study.
- Subject likely to receive treatments prohibited in the protocol during the trial.
- Cardiovascular, hepatic, neurological, endocrine or any other disease making it difficult to carry out the protocol or interpret the results.
- Proliferative or rapidly progressive or unstable retinopathy for at least 6 months after treatment by surgery or laser, or requiring surgery or laser in the 3 months following inclusion in the study.
- Hepatic impairment:ALT and/or AST more than three times the upper limit of normal at the initial assessment.
- Renal insufficiency:Serum creatinine >177 µmol/l (>20 mg/l) or creatinine clearance <60 ml/min.
- Previous or current history of alcohol or drug abuse.
- Mental state rendering the subject incapable of understanding the nature, objectives and possible consequences of the trial.
- Inability to undertake blood glucose self-monitoring and the injection of insulin alone.
- Subject unable to accept the restrictions of the protocol (uncooperative, unable to attend the follow-up visits and probably incapable of completing the trial).
- Subjects deprived of freedom by an administrative or judicial decision.
- 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
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
Primary objective:
The primary objective of this trial is:
Read more
- To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not optimal on maximum oral treatment, based on the number of patients achieving a HbA1c value < 7% at the end of treatment.
Secondary objectives:
The secondary objectives of this trial are to compare between the two treatment groups:
- The variation in HbA1c between baseline and end of trial.
- The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.
- Mean blood glucose levels at different times of the day.
- The variation in weight and lipid in each group between baseline and end of trial.
- The incidence of adverse events.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine
- 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 GlargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving HbA1c < 7% at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2003
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174681
- Sponsor's protocol ID
- HOE901_4042
- Status last verified
- Jan 2011
- First submitted
- 9 Sep 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00174681
- Acronym / sponsor ID
- HOE901_4042
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- First posted
- 15 Sep 2005 (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.
Primary objective:
The primary objective of this trial is:
- To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not optimal on maximum oral treatment, based on the number of patients achieving a HbA1c value < 7% at the end of treatment.
Secondary objectives:
The secondary objectives of this trial are to compare between the two treatment groups:
- The variation in HbA1c between baseline and end of trial.
- The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.
- Mean blood glucose levels at different times of the day.
- The variation in weight and lipid in each group between baseline and end of trial.
- The incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects fulfilling all of the following criteria will be eligible for inclusion in the trial:
- Type 2 diabetes
- 24 ≤ BMI ≤ 35 kg/m2
- 7 % ≤ HbA1c ≤ 8 %
- Treated with OAD for at least 2 years
Key exclusion criteria (20 listed)
- Type 1 diabetics
- Insulin-treated type 2 diabetics or having previously received long-term insulin, or treated with a thiazolidinedione or glinide
- Fasting blood glucose < 1.20 g/l.
- Pregnancy (non-menopausal women must have a pregnancy test before the inclusion visit and effective contraception).
- Lactation.
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
Percentage of subjects achieving HbA1c < 7% at the end of the study.
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 11 Jan 2011.
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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.
Valérie Pilorget, MD study director
Sanofi
6 sites in 6 countries: 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, Type 2, run by Sanofi at 6 sites in 6 countries.
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 9 inclusion and 20 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 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Croatia, Czechia, France, Romania, Russia and 1 more country. 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?
Percentage of subjects achieving HbA1c < 7% at the end of the study.. 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 11 Jan 2011.