Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients

Inclusion Criteria: * diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test); * HbA1c between 6.5-8.5 % (confirmed in the previous 3 months), * capable of using oral nutritional supplementation, * on stable and controlled anti-diabetic regime for at least 1 months, * use of metformin and/or sulphonylureas as oral anti-diabetic medication, * in need of nutritional support because of ≥5% involuntary weight loss in the last 3 months, ≥10% involuntary weight loss in the last 6 months, inadequate nutritional intake causing failure to meet nutritional requirements or at risk of developing malnutrition Exclusion Criteria: * diabetes type 1, * participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start * patients requiring a fibre free diet, * enteral tube feed or parenteral nutrition, * concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas, * known or suspected intolerance or allergy to any component of the investigational product(s), * any acute gastrointestinal disease within 2 weeks prior to study entry, * gastrectomy, gastroparesis or other gastric emptying abnormalities, * acute sever heart failure (NYHA class 4), liver insufficiency / failure (male: ALAT \> 150 U/l; female: ALAT \> 120 U/l) or renal failure requiring dialysis, * cancer cachexia, * galactosaemia, fructosaemia, * suspicion of drug abuse, abuse of/addiction to alcohol, * pregnant or breast feeding women, or fertile women refusing to use contraceptives, * patients with untreated major psychiatric disorder, * known HIV positive (safety reasons), * patient unable to co-operate adequately