Quantification of the Dipeptidyl Peptidase (DPP)-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis
Quantification of the DPP-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis
2 other identifiers
interventional
20
1 country
1
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 load and an 'isoglycaemic' intravenous glucose load). Hypothesis: Treatment with co-administration of sitagliptin and metformin provides a greater incretin effect compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes
Started Feb 2009
Longer than P75 for phase_2 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 18, 2015
December 1, 2015
3.8 years
May 21, 2008
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effect of 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)
24 weeks
Secondary Outcomes (1)
To assess the effect of sitagliptin compared with placebo on the incretin effect (based on the comparison of the insulin secretory response to oral glucose load and an 'isoglycaemic' intravenous glucose load)
24 weeks
Study Arms (4)
Treatment A
ACTIVE COMPARATORsitagliptin and placebo
Treatment B
ACTIVE COMPARATORplacebo and metformin
Treatment C
ACTIVE COMPARATORsitagliptin and metformin
Treatment D
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael A. Naucklead
Study Sites (1)
Diabeteszentrum Bad Lauterberg
Bad Lauterberg im Harz, 37431, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Nauck, Prof. Dr.
Diabeteszentrum Bad Lauterberg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
February 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
December 18, 2015
Record last verified: 2015-12