Study Stopped
PI left JHU
Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)
The Effect of Dipeptidyl Peptidase-4 Inhibition on GLP-1 Induced Insulin Secretion and Glucose Turnover During Mild Stable Hyperglycemia in Young and Old Normal Volunteers
1 other identifier
interventional
12
1 country
1
Brief Summary
This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 12, 2017
CompletedJuly 12, 2017
June 1, 2017
1 year
July 24, 2009
May 1, 2017
June 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin Release Rate and Hepatic Glucose Release
One year
Secondary Outcomes (1)
Peripheral Glucose Utilization and Peripheral Glucagon Release
one year
Study Arms (2)
Placebo
PLACEBO COMPARATORJanuvia
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Hct level of at least 34% for women and 36% for men
- Women of non-bearing potential and women of childbearing potential using adequate contraception
- Serum creatine level of less than 1.7 mg/dl
- Four groups:
- Age 21-45 (BMI between 18.50-24.99) \& (BMI between 30-35)
- Age greater than 65 years (BMI between 18.50-24.99) \& (BMI between 30-35)
You may not qualify if:
- Pregnant and/or lactating females
- Women of childbearing potential not willing to use adequate contraception
- Serum creatine level greater than 1.8 mg/dl
- Age less than 21 and age between 46-64
- Diabetes mellitus
- BMI less than 18 and BMI greater than 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johns Hopkins University Clinical Trials Program
- Organization
- Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Dariush Elahi, PhD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 27, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 12, 2017
Results First Posted
July 12, 2017
Record last verified: 2017-06