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summarize your comments on the advantages, disadvantages, and outcome measures. from the below clinical trial study

summarize your comments on the advantages, disadvantages, and outcome measures. from the below clinical trial study

summarize your comments on the advantages, disadvantages, and outcome measures. from the below clinical trial study

300 words each no plagiarism please no bullet points

1 Advantages

2 Disadvantages

3 Outcome measure

In the first phase of the Treating to Target in Type 2 Diabetes (4-T) study, we evaluated patients with type 2 diabetes who had suboptimal glycemic control despite maximally tolerated doses of metformin and sulfonylurea to see whether the randomized addition of a biphasic, prandial, or basal analog insulin would lead to clinically relevant improvement in glycated hemoglobin levels during a 1-year period.4 Although the intensification of insulin therapy reduces glycated hemoglobin levels,5 it is not clear which complex regimen best achieves glycemic targets.6 The choice of insulin regimen varies widely according to country, but large-scale direct comparisons of complex insulin regimens have not been performed. Here we report 3-year results comparing the three insulin regimens in which sulfonylurea therapy was replaced by the second type of insulin if glycated hemoglobin levels of 6.5% or less were not achieved with a single type of insulin.

STUDY DESIGN

Patients were randomly assigned to receive twice-daily biphasic insulin aspart (NovoMix 30), three-times-daily prandial insulin aspart (NovoRapid), or once-daily (twice if required) basal insulin detemir (Levemir). Patients injected doses of biphasic and prandial insulin immediately before meals and basal insulin at bedtime. All three preparations were supplied by Novo Nordisk in 3-ml disposable-pen devices (FlexPen). During the first year of the study, sulfonylurea therapy was replaced by the second type of insulin if hyperglycemia became unacceptable (a glycated hemoglobin level of >10.0% or two consecutive values of ≥8.0% at or after 24 weeks of therapy) or subsequently if glycated hemoglobin levels were more than 6.5%.4 For the biphasic-based regimen, midday prandial insulin was added, starting with 10% of the current total daily biphasic insulin dose and limited to a minimum of 4 units and a maximum of 6 units. For the prandial-based regimen, basal insulin (10 units) was added at bedtime. For the basal-based regimen, prandial insulin was added at breakfast, lunch, and dinner, starting with 10% of the current total daily dose of basal insulin at each time point and limited to a minimum of 4 units and a maximum of 6 units. First-year visits with patients were scheduled at 2, 6, 12, 24, 38, and 52 weeks, with interim telephone contact. After the first year, visits were scheduled every 3 months, with patients asked in advance to perform three daily capillary glucose profiles (Medisense Optium, Abbott).4 Using these profiles and data regarding self-reported hypoglycemia, the trial-management system4 suggested changes in the insulin dose, aiming for glucose values before meals of 72 to 99 mg per deciliter (4.0 to 5.5 mmol per liter) and values 2 hours after meals of 90 to 126 mg per deciliter (5.0 to 7.0 mmol per liter). Investigators and patients were encouraged to vary suggested insulin doses, as clinically appropriate, and to amend the doses between visits. Hypoglycemia was categorized as grade 1 (symptoms only) if a patient had symptoms with a self-measured capillary glucose level of 56 mg per deciliter (3.1 mmol per liter) or more, grade 2 (minor) if the patient had symptoms with a self-measured capillary glucose level of less than 56 mg per deciliter, or grade 3 (major) if third-party assistance was required.4 The trial steering committee consisted of five academic members, one lay member, and three representatives of Novo Nordisk, the sponsor. Only academic members had access to the non safety data. All authors vouch for the accuracy, integrity, and completeness of the reported data, which were collected and analyzed by the Diabetes Trials Unit.

PRIMARY AND SECONDARY OUTCOMES The primary 3-year outcome was the glycated hemoglobin level. Secondary outcomes were the proportion of patients with a glycated hemoglobin level of 6.5% or less, the proportion of patients with a glycated hemoglobin level of 6.5% or less but without hypoglycemia of grade 2 or more, weight gain, self-measured capillary glucose profiles, the proportion of patients requiring a second type of insulin, the ratio of albumin to creatinine, and quality of life.

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