Status:
COMPLETED
Quantification of the Dipeptidyl Peptidase (DPP)-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis
Lead Sponsor:
Michael A. Nauck
Conditions:
Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Objective: To assess the effect if co-administration of sitagliptin and metformin compared to placebo on the incretin effect (based on the comparison of the insulin secretory response to oral glucose ...
Detailed Description
A new class of antidiabetic agents, the DPP-4 inhibitors, are thought to protect endogenously secreted incretin hormones (e.g., GLP-1 and GIP) from proteolytic degradation and inactivation. Since GLP-...
Eligibility Criteria
Inclusion
- Type 2-diabetes mellitus
- BMI 25-35 kg/m2
- HbA1c 6.5%-9% (without OHA medication)
- HbA1c 6%-8.5% (OHA monotherapy with metformin or sulfonylurea)
- Patient understands the study-procedures
Exclusion
- Type 1-diabetes mellitus
- C-peptide \< 0.7ng/mL (0.23 nmol/L)
- Patient has been taking oral anti-hyperglycemic agent (OHA) within the prior 12 weeks, except metformin or a sulfonylurea
- Patient has required insulin therapy within the past 12 weeks
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00683735
Start Date
February 1 2009
End Date
December 1 2013
Last Update
December 18 2015
Active Locations (1)
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1
Diabeteszentrum Bad Lauterberg
Bad Lauterberg im Harz, Germany, 37431