Type 2 diabetes mellitus
Conditions
Interventions
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 25 or 50 g of carbohydrate (50% glucose and
Sponsors
DSM Food Specialties
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females, 18-70 years old. 2. Fasting glucose level > 7 mmol/L after 2 days refraining from medication. 3. Are on stable medication with biguanides for at least 3 months. 4. Prepared and able to give written informed consent;
Exclusion criteria
Exclusion criteria: 1. Use of insulin, sulfonylurea derivatives, meglitinides or other antidiabetic drugs except biguanides. 2. BMI > 35 kg/m2. 3. Females who are pregnant, have the intention to become pregnant within the study period, or who are lactating. 4. 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). 5. Uncontrolled hypertension. 6. Active, proliferative retinopathy 7. 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). 8. Participation in a trial within 3 months prior to the start of the study or more then 4 times a year. 9. Loss of 250 ml or more of blood within 3 months prior to screening. 10. 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 | — |
Contacts
Public ContactJ.W.A. Smit
Department of Endocrinology Leiden University Medical Center
Outcome results
None listed