Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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/study/NCT00405418
Trial related presentations / 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.
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/study/NCT00405418