diabetes mellitus type 2
Conditions
Interventions
Part I: The treatments will consist of a drink that will be freshly prepared
prior to use. The drink will be administered as a single oral bolus (300 mL)
containing 50 g of carbohydrate (50% glucose
Sponsors
DSM Food Specialties
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Males or females, 18-70 years old. • Fasting glucose level > 7 mmol/L after 2 days refraining from medication. • Are on stable medication with biguanides for at least 3 months. • Prepared and able to give written informed consent;
Exclusion criteria
Exclusion criteria: • Use of insulin, sulfonylurea derivatives, meglitinides or other antidiabetic drugs except biguanides; • BMI > 35 kg/m2; • Females who are pregnant, have the intention to become pregnant within the study period, or who are lactating; • A present and clinically significant history of ischemic heart disease (such as angina pectoris with an incidence of more than one attack/month), acute myocardial infarction within one year prior to the study or congestive heart failure (defined as NYHA class III or IV); • Uncontrolled hypertension; • Active, proliferative retinopathy • Active or history of liver disease or impaired renal function (defined as a creatinin clearance calculated with the Cockcroft-Gault formula below 60 ml/min); • Participation in a trial within 3 months prior to the start of the study or more then 4 times a year; • Loss of 250 ml or more of blood within 3 months prior to screening; • Any clinical condition, including use of co-medication or laboratory test results that in the opinion of the investigators may jeopardize the health status of the participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentrations and AUC of glucose and insulin. | — |
Countries
Netherlands
Outcome results
None listed