Glycemic Control in Patients With Type 2 Diabetes Mellitus With a Disease-Specific Enteral Formula: Stage II of a Randomized, Controlled Multicenter Trial

Background: Stage I of a preplanned 2-stage study has provided good evidence for improved glycemic control with a disease-specific enteral formula low in carbohydrates and high in monounsaturated fatty acids (MUFAs), fish oil, chromium, and antioxidants with stage II to give confirmatory proof of these beneficial effects. Methods: 105 patients with Hba(1c) >= 7.0% and/or fasting blood glucose (FG) > 6.7 mmol/L (> 120mg/dL) requiring enteral tube feeding due to neurological dysphagia received 113 kJ (27 kcal)/kg body weight of either test formula (Diven) or an isoenergetic, isonitrogenous standard formula (control) for up to 84 days. Total insulin (TI) requirements. FG, an afternoon blood glucose (AG) were assessed daily. HbA(1c) and safety criteria were evaluated on days 1.28.56 and 84. Results: 55 patients completed the study: on day 84, median changes from baseline (data as available, test vs control) were the following: TI, -8.0 vs + 2.0 IU; FG -2.17 vs -0.67 mmol/L (-39.0 vs -12.1 mg/dL); HbA(1c), -1.30% vs -1.20%; AG, -2.36 vs -0.49 mmol/L (-4.25 vs -8.9 mg/dL). The number of relevant hypoglycemic episodes (FG < 3.33 mmol/L < 60 mg/dL) was 1 vs 5. Feeding tolerance was comparanle in both groups. Conclusions: Long-term tube feeding with a disease-specific enteral formula was safe and well tolerated in type 2 diabetic patients with neurological disorders. When compared with a standard diet. TI requirement decreased significantly with less hypoglycemia whereas FG and AG were significantly lowered, resulting in improved glycemic control.