Lantus Versus Levemir Treat-To-Target
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00405418
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 973
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Insulin glargine Insulin Glargine 2 Insulin Detemir Insulin Detemir
- Primary Outcome Measures
Name Time Method HbA1c recorded At baseline, week 12 and week 24 Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm On the 4 consecutive days before each visit Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days 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) All across the study Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia. All across the study
- Secondary Outcome Measures
Name Time Method Doses of insulin glargine or insulin detemir Daily Laboratory fasting plasma glucose At baseline, week 12 and week 24 Insulinemia and fasting C-peptide level At baseline Lipid profile at baseline and week 24 Patient reported outcomes (quality of life and treatment satisfaction) at baseline, week 4, week 12 and at the last visit Safety data: occurrence of adverse events and weight assessed at each visit Waist and hip circumferences measured at baseline, week 12 and week 24 Systolic and diastolic blood pressure measured at study entry, baseline, week 12 and week 24 Physical examination performed at study entry and at last visit.
Trial Locations
- Locations (1)
Sanofi-Aventis
🇬🇧Guildford, United Kingdom