Diabetes Mellitus, Type 2Phase 4L2T3NCT00405418
Lantus Versus Levemir Treat-To-Target
A Phase 4 study testing Insulin glargine and Insulin Detemir in people with Diabetes Mellitus, Type 2, run by Sanofi at 20 sites in 20 countries.
Trial summary
Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L)… 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 and Insulin Detemir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 973 participants
- Where
- 20 sitesin 20 countries
- Study dates
- Nov 2006to Jun 2008
- 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
- Type 2 diabetes for at least 1 year
- Insulin naïve
- Treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
- 7% ≤ HbA1c ≤ 10.5 %
- Body mass index (BMI) < 40 kg/m²
- Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
Who cannot join
- Type 1 diabetes
- Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
- Treatment with glucagon-like peptide (GLP)-1 receptor agonists or with dipeptidyl peptidase (DPP)-IV inhibitors
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
- Breast-feeding
Show all 15Show fewer
- History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- Treatment with systemic corticosteroids in the 3 months prior to study entry
- Treatment with any investigational product in the 2 months prior to study entry
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
- Impaired renal function as shown by serum creatinine ≥ 1.5 mg/dL (≥ 133 μmol/L) in men and ≥ 1.4 mg/dL (124 μmol/L) in women at study entry
- History of drug or alcohol abuse in the last year
- 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
20 sites in 20 countries.
20 sites in 20 countries
About this study
Official title: Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir.
Primary objective:
To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L)
Read more
Secondary objectives:
- To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period
- To compare the changes in HbA1c and fasting plasma glucose (FPG)
- To compare the evolution of blood glucose profiles
- To compare the day to day FPG variability, the insulin doses
- To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets
- To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)
- To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL
- To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio
- To assess the quality of life and treatment satisfaction
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glargine, Insulin Detemir
- 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
Subcutaneous injection, once a day in the evening
Insulin DetemirDrug
Subcutaneous injection, twice a day at breakfast and before dinner
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin Glargine Receives: Drug: Insulin glargine |
| 2 | Active comparator | Insulin Detemir Receives: Drug: Insulin Detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c recorded
Measured: At baseline, week 12 and week 24
Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm
Measured: On the 4 consecutive days before each visit
Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days
Measured: Within the week prior to baseline, week 12 and week 24
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)
Measured: All across the study
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.
Measured: All across the study
Secondary outcomes (9)
Doses of insulin glargine or insulin detemir
Measured: Daily
Laboratory fasting plasma glucose
Measured: At baseline, week 12 and week 24
Insulinemia and fasting C-peptide level
Measured: At baseline
Lipid profile
Measured: at baseline and week 24
Patient reported outcomes (quality of life and treatment satisfaction)
Measured: at baseline, week 4, week 12 and at the last visit
Safety data: occurrence of adverse events and weight
Measured: assessed at each visit
Waist and hip circumferences
Measured: measured at baseline, week 12 and week 24
Systolic and diastolic blood pressure
Measured: measured at study entry, baseline, week 12 and week 24
Physical examination
Measured: performed at study entry and at last visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405418
- Sponsor's protocol ID
- LANTU_C_00579
- Other IDs
- EUDRACT # : 2006-000324-13
- Acronym
- L2T3
- Status last verified
- Sep 2009
- First submitted
- 29 Nov 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
Publications
Swinnen SG, Dain MP, Aronson R, Davies M, Gerstein HC, Pfeiffer AF, Snoek FJ, Devries JH, Hoekstra JB, Holleman F. A 24-week, randomized, treat-to-target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs. Diabetes Care. 2010 Jun;33(6):1176-8. doi: 10.2337/dc09-2294. Epub 2010 Mar 3.
PubMed 20200301
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir.
- ClinicalTrials.gov ID
- NCT00405418
- Acronym / sponsor ID
- L2T3 / LANTU_C_00579
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jun 2008 (actual)
- First posted
- 30 Nov 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.
Primary objective:
To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L)
Secondary objectives:
- To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period
- To compare the changes in HbA1c and fasting plasma glucose (FPG)
- To compare the evolution of blood glucose profiles
- To compare the day to day FPG variability, the insulin doses
- To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets
- To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)
- To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL
- To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio
- To assess the quality of life and treatment satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin glargineInsulin Glargine |
| 2 | Active comparator | Drug: Insulin DetemirInsulin Detemir |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes for at least 1 year
- Insulin naïve
- Treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
- 7% ≤ HbA1c ≤ 10.5 %
- Body mass index (BMI) < 40 kg/m²
Key exclusion criteria (15 listed)
- Type 1 diabetes
- Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
- Treatment with glucagon-like peptide (GLP)-1 receptor agonists or with dipeptidyl peptidase (DPP)-IV inhibitors
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
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 glargineSubcutaneous injection, once a day in the evening | Drug | 1 |
| Insulin DetemirSubcutaneous injection, twice a day at breakfast and before dinner | Drug | 2 |
Primary outcome
HbA1c recorded
Time frame: At baseline, week 12 and week 24
Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm
Time frame: On the 4 consecutive days before each visit
Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days
Time frame: Within the week prior to baseline, week 12 and week 24
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)
Time frame: All across the study
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.
Time frame: All across the study
9 secondary outcomes
Doses of insulin glargine or insulin detemir
Time frame: Daily
Laboratory fasting plasma glucose
Time frame: At baseline, week 12 and week 24
Insulinemia and fasting C-peptide level
Time frame: At baseline
Lipid profile
Time frame: at baseline and week 24
Patient reported outcomes (quality of life and treatment satisfaction)
Time frame: at baseline, week 4, week 12 and at the last visit
Safety data: occurrence of adverse events and weight
Time frame: assessed at each visit
Waist and hip circumferences
Time frame: measured at baseline, week 12 and week 24
Systolic and diastolic blood pressure
Time frame: measured at study entry, baseline, week 12 and week 24
Physical examination
Time frame: performed at study entry and at last visit.
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 Sep 2009.
- Derived from this study: PubMed 20200301Swinnen SG, Dain MP, Aronson R, Davies M, Gerstein HC, Pfeiffer AF, Snoek FJ, Devries JH, Hoekstra JB, Holleman F. A 24-week, randomized, treat-to-target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs. Diabetes Care. 2010 Jun;33(6):1176-8. doi: 10.2337/dc09-2294. Epub 2010 Mar 3.
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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 study director
Sanofi
20 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin glargine and Insulin Detemir in people with Diabetes Mellitus, Type 2, run by Sanofi at 20 sites in 20 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 6 inclusion and 15 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 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, Brazil, Canada, Denmark, Finland and 15 more countries. 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?
HbA1c recorded (time frame: At baseline, week 12 and week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00405418, which also lists 1 linked publication.
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 Sep 2009.