Dietary interventions’s impact on HbA1c and hypoglycemia also assessed….
This trial was 26 weeks long, randomized, open-label and occurred across nine different countries. The study participants were insulin-naïve overweight or obese (BMI 25-45kg/m2) patients 18 years and older with T2DM for ≥6 months and inadequately controlled with metformin and/or other antidiabetic drugs. Patients also were required to have an A1c of 7-9%.
Study participants were randomized to either the once-daily insulin determir group with basic lifestyle advice or to a second group with once-daily insulin detemir, basic lifestyle advice, and a dietary intervention. The patients all received their insulin once daily either with their evening meal or at bedtime with metformin. Patients in the dietary intervention group received the same basic lifestyle advice as those in the first group plus 3 face-to-face meetings and 3 phone consultations with a dietitian. The dietitians assessed the patient’s dietary intake, set caloric goals, provided a meal plan and a food diary, and gave diet adherence tips. The primary endpoint for this study was weight change from baseline to the end of the trial. Some of the secondary endpoints included: changes in BMI, A1c, fasting plasma glucose, change in waist circumference, change in caloric intake, and change in physical activity from baseline to the end of the study.
Weight loss was observed for both groups from baseline to trial completion. No significant change was found between the two groups with regards to weight loss, showing that dietary intervention did not make a significant difference for this outcome. Initiation of insulin detemir was found to improve glycemic control in both groups, which supports the findings of previous studies that observed the effects of insulin detemir on patients previously taking OAD’s. The group with the dietary intervention did however have slightly more HbA1c responders without hypoglycemia and without weight gain versus the group without the dietary intervention, though there was no difference observed between the two groups when it came to proportion of patients meeting target A1c. As this was a multinational study, the results are more likely to be applicable to various different counties, though this could also be a limitation as a small number of patients were obtained from a large number of sites. A possible confounder in this study is that about half of the patients were on sulfonylurea therapy before the trial began. These patients then discontinued this medication after the trial began, which may have accounted for some of the weight loss. Overall, though, this study found that dietary intervention in addition to basic lifestyle advice had a similar effect on average weight loss as basic lifestyle advice alone.
- Additional dietary intervention was not found to increase weight loss in this patient population.
- Dietary intervention was found to slightly increase the proportion of patients reaching an A1c <7% without hypoglycemia or weight gain.
Niswender, K. "Weight change upon once-daily initiation of insulin detemir with or without dietary intervention in overweight or obese insulin-naïve individuals with type 2 diabetes: results from the DIET trial" Diabetes, Obesity and Metabolism. 2014; 16:186-192.