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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00405418




Registration number
NCT00405418
Ethics application status
Date submitted
29/11/2006
Date registered
30/11/2006
Date last updated
15/09/2009

Titles & IDs
Public title
Lantus Versus Levemir Treat-To-Target
Scientific 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.
Secondary ID [1] 0 0
EUDRACT # : 2006-000324-13
Secondary ID [2] 0 0
LANTU_C_00579
Universal Trial Number (UTN)
Trial acronym
L2T3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin glargine
Treatment: Drugs - Insulin Detemir

Experimental: 1 - Insulin Glargine

Active Comparator: 2 - Insulin Detemir


Treatment: Drugs: Insulin glargine
Subcutaneous injection, once a day in the evening

Treatment: Drugs: Insulin Detemir
Subcutaneous injection, twice a day at breakfast and before dinner
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c recorded
Timepoint [1] 0 0
At baseline, week 12 and week 24
Primary outcome [2] 0 0
Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm
Timepoint [2] 0 0
On the 4 consecutive days before each visit
Primary outcome [3] 0 0
Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days
Timepoint [3] 0 0
Within the week prior to baseline, week 12 and week 24
Primary outcome [4] 0 0
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)
Timepoint [4] 0 0
All across the study
Primary outcome [5] 0 0
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.
Timepoint [5] 0 0
All across the study
Secondary outcome [1] 0 0
Doses of insulin glargine or insulin detemir
Timepoint [1] 0 0
Daily
Secondary outcome [2] 0 0
Laboratory fasting plasma glucose
Timepoint [2] 0 0
At baseline, week 12 and week 24
Secondary outcome [3] 0 0
Insulinemia and fasting C-peptide level
Timepoint [3] 0 0
At baseline
Secondary outcome [4] 0 0
Lipid profile
Timepoint [4] 0 0
at baseline and week 24
Secondary outcome [5] 0 0
Patient reported outcomes (quality of life and treatment satisfaction)
Timepoint [5] 0 0
at baseline, week 4, week 12 and at the last visit
Secondary outcome [6] 0 0
Safety data: occurrence of adverse events and weight
Timepoint [6] 0 0
assessed at each visit
Secondary outcome [7] 0 0
Waist and hip circumferences
Timepoint [7] 0 0
measured at baseline, week 12 and week 24
Secondary outcome [8] 0 0
Systolic and diastolic blood pressure
Timepoint [8] 0 0
measured at study entry, baseline, week 12 and week 24
Secondary outcome [9] 0 0
Physical examination
Timepoint [9] 0 0
performed at study entry and at last visit.

Eligibility
Key inclusion criteria
- 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
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
973
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paolo
Country [2] 0 0
Canada
State/province [2] 0 0
Laval
Country [3] 0 0
Denmark
State/province [3] 0 0
Hoersholm
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
India
State/province [6] 0 0
Mumbai
Country [7] 0 0
Ireland
State/province [7] 0 0
Dublin
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Netherlands
State/province [9] 0 0
Gouda
Country [10] 0 0
Portugal
State/province [10] 0 0
Porto Salvo
Country [11] 0 0
Romania
State/province [11] 0 0
Bucharest
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Moscow
Country [13] 0 0
Serbia
State/province [13] 0 0
Belgrade
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Sweden
State/province [15] 0 0
Stockholm
Country [16] 0 0
Switzerland
State/province [16] 0 0
Meyrin
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taipe
Country [18] 0 0
Turkey
State/province [18] 0 0
Istanbul
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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)

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00405418
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Valérie Pilorget
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00405418