OBJECTIVE: the AT-LANTUS Study demonstrated that a simple subject-administered titration algorithm significantly improved glycemic control with a low incidence of severe hypoglycemia compared with a physician-managed titration. However, in the AT-LANTUS Study Asian patients were under-represented, and more than 70% of the patients were already treated with insulin. The Asian Treat to Target Lantus Study (ATLAS) will compare the effectiveness of a patient- versus physician-led initiation of insulin glargine-based basal management in the specific setting of Asia and Russia (as is routinely used in Western countries). This report presents the study design of ATLAS. METHODS:subjects are 40-75 years old (body mass index ≥ 20 and ≤ 40 kg/m(2)) with type 2 diabetes mellitus (T2DM) of >2 years in duration, suboptimally controlled (hemoglobin A1c [HbA1c] ≥ 7.0% and ≤ 11%) with stable doses of two oral antidiabetes drugs (OADs) (sulfonylureas, biguanides, α-glucosidase inhibitors, dipeptidyl peptidase-IV inhibitors, and glinides) for more than 3 months, and not using insulin. The subjects will be randomized to either the patient-led or the physician-led titration arm, where the insulin dose will be adjusted to achieve a target fasting plasma glucose (FPG) value of 110 mg/dL (6.1 mmol/L). STUDY OUTCOMES: the primary outcome will be change in mean HbA1c at 6 months from baseline. The analysis plan prespecifies a hierarchical testing procedure for the primary outcome. If noninferiority is achieved using a 0.3% HbA1c boundary, we will go on to undertake a test for superiority. Secondary outcomes will also include number of patients reaching American Diabetes Association targetHbA1c with or without hypoglycemia and analysis of FPG profiles in the two groups. CONCLUSIONS: ATLAS will provide information on the relative safety and efficacy of a patient- versus physician-led titration strategy for insulin glargine-based basal insulin initiation in patients who are not controlled with two OADs in Asia and Russia. The results of the study may guide policymakers to translate data into clinical practice.
RCT Entities:
OBJECTIVE: the AT-LANTUS Study demonstrated that a simple subject-administered titration algorithm significantly improved glycemic control with a low incidence of severe hypoglycemia compared with a physician-managed titration. However, in the AT-LANTUS Study Asian patients were under-represented, and more than 70% of the patients were already treated with insulin. The Asian Treat to Target Lantus Study (ATLAS) will compare the effectiveness of a patient- versus physician-led initiation of insulinglargine-based basal management in the specific setting of Asia and Russia (as is routinely used in Western countries). This report presents the study design of ATLAS. METHODS: subjects are 40-75 years old (body mass index ≥ 20 and ≤ 40 kg/m(2)) with type 2 diabetes mellitus (T2DM) of >2 years in duration, suboptimally controlled (hemoglobin A1c [HbA1c] ≥ 7.0% and ≤ 11%) with stable doses of two oral antidiabetes drugs (OADs) (sulfonylureas, biguanides, α-glucosidase inhibitors, dipeptidyl peptidase-IV inhibitors, and glinides) for more than 3 months, and not using insulin. The subjects will be randomized to either the patient-led or the physician-led titration arm, where the insulin dose will be adjusted to achieve a target fasting plasma glucose (FPG) value of 110 mg/dL (6.1 mmol/L). STUDY OUTCOMES: the primary outcome will be change in mean HbA1c at 6 months from baseline. The analysis plan prespecifies a hierarchical testing procedure for the primary outcome. If noninferiority is achieved using a 0.3% HbA1c boundary, we will go on to undertake a test for superiority. Secondary outcomes will also include number of patients reaching American Diabetes Association target HbA1c with or without hypoglycemia and analysis of FPG profiles in the two groups. CONCLUSIONS: ATLAS will provide information on the relative safety and efficacy of a patient- versus physician-led titration strategy for insulinglargine-based basal insulin initiation in patients who are not controlled with two OADs in Asia and Russia. The results of the study may guide policymakers to translate data into clinical practice.