Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGInsulin glargine
Subcutaneous injection, once a day in the evening
DRUGInsulin Detemir
Subcutaneous injection, twice a day at breakfast and before dinner
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety data: occurrence of adverse events and weight | assessed at each visit |
| Waist and hip circumferences | measured at baseline, week 12 and week 24 |
| Doses of insulin glargine or insulin detemir | Daily |
| Physical examination | performed at study entry and at last visit. |
| Systolic and diastolic blood pressure | measured at study entry, baseline, week 12 and week 24 |
| 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 |
Countries
Australia, Brazil, Canada, Denmark, Finland, Germany, India, Ireland, Netherlands, Portugal, Romania, Russia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Outcome results
None listed