The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM) (NCT01449019) | Clinical Trial Compass
CompletedPhase 1
The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)
Germany24 participantsStarted 2006-12
Plain-language summary
The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide 1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in healthy subjects and patients with type 2 diabetes mellitus (T2DM).
Who can participate
Age range30 Years – 70 Years
SexALL
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Inclusion Criteria:
* male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy subjects and patients with type 2 diabetes mellitus (T2DM)
* must be able to complete a 1 week wash-out of current anti-diabetic medications
* Age 30-70 years
* HbA1c (Hemoglobin A1c) ≤11% at screening
* Body mass index (BMI) \<40 kg/m2
* Patients with type 2 diabetes mellitus (T2DM): Must have a fasting blood glucose of ≤12.2 mmol/L (240 mg/dL) at screening
* Able to provide written informed consent prior to study participation
* Able to communicate well with the investigator and comply with the requirements of the study
Exclusion Criteria:
* Patients with type 1 diabetes mellitus (T1DM), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg Cushing, acromegaly)
* Need for insulin within the previous 3 months
* Use of Thiazolidinediones in the previous 4 weeks
* Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).
* Treatment with systemic steroids and thyroid hormone (unstable dosage).
* Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* Significant illness within the two weeks prior to dosing.…
What they're measuring
1
The incretin effect
Timeframe: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion