Lantus Versus Levemir Treat-To-Target (L2T3)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin Detemir

Drug: Insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00405418

LANTU_C_00579

EUDRACT # : 2006-000324-13

Details and patient eligibility

About

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

Enrollment

973 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

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