Diabetes Mellitus, Type 2 Clinical Trial
— L2T3Official 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.
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
Status | Completed |
Enrollment | 973 |
Est. completion date | |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Sanofi-Aventis | North Ryde | |
Brazil | Sanofi-Aventis | Sao Paolo | |
Canada | Sanofi-Aventis | Laval | |
Denmark | Sanofi-Aventis | Hoersholm | |
Finland | Sanofi-Aventis | Helsinki | |
Germany | Sanofi-Aventis | Berlin | |
India | Sanofi-Aventis | Mumbai | |
Ireland | Sanofi-Aventis | Dublin | |
Korea, Republic of | Sanofi-Aventis | Seoul | |
Netherlands | Sanofi-Aventis | Gouda | |
Portugal | Sanofi-Aventis | Porto Salvo | |
Romania | Sanofi-Aventis | Bucharest | |
Russian Federation | Sanofi-Aventis | Moscow | |
Serbia | Sanofi-Aventis | Belgrade | |
Spain | Sanofi-Aventis | Barcelona | |
Sweden | Sanofi-Aventis | Stockholm | |
Switzerland | Sanofi-Aventis | Meyrin | |
Taiwan | Sanofi-Aventis | Taipe | |
Turkey | Sanofi-Aventis | Istanbul | |
United Kingdom | Sanofi-Aventis | Guildford |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Australia, Brazil, Canada, Denmark, Finland, Germany, India, Ireland, Korea, Republic of, Netherlands, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c recorded | At baseline, week 12 and week 24 | No | |
Primary | Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm | On the 4 consecutive days before each visit | No | |
Primary | 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 | No | |
Primary | Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic) | All across the study | No | |
Primary | Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia. | All across the study | No | |
Secondary | Doses of insulin glargine or insulin detemir | Daily | No | |
Secondary | Laboratory fasting plasma glucose | At baseline, week 12 and week 24 | No | |
Secondary | Insulinemia and fasting C-peptide level | At baseline | No | |
Secondary | Lipid profile | at baseline and week 24 | No | |
Secondary | Patient reported outcomes (quality of life and treatment satisfaction) | at baseline, week 4, week 12 and at the last visit | No | |
Secondary | Safety data: occurrence of adverse events and weight | assessed at each visit | Yes | |
Secondary | Waist and hip circumferences | measured at baseline, week 12 and week 24 | No | |
Secondary | Systolic and diastolic blood pressure | measured at study entry, baseline, week 12 and week 24 | No | |
Secondary | Physical examination | performed at study entry and at last visit. | No |
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