Quantification of the Dipeptidyl Peptidase (DPP)-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 load and an 'isoglycaemic' intravenous glucose load). Hypothesis: Treatment with co-administration of sitagliptin and metformin provides a greater incretin effect compared to placebo.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael A. Nauck
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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