Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)

NCTNCT00947011Other idNA_00018441

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: PI left JHU

Results were posted for this trial.

This trial does not test a peptide that PepBank tracks.

Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 12 participants (actual)
Sponsor: Johns Hopkins University · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Mar 2009
Primary completion: Mar 2010
Completion: Mar 2010
First posted: 27 Jul 2009 (estimated)
Last update posted: 12 Jul 2017
Conditions: Glucose Homeostasis

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

Ph 2
Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)
NCT00947011
Mar 2009 to Mar 2010
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PlaceboDrug
JanuviaDrug

Arms2

Placebo comparator
Placebo
Active comparator
Januvia

Primary outcomes1

Outcomes the sponsor listed as primary.

Insulin Release Rate and Hepatic Glucose Release
Time frame · One year

Secondary outcomes(1)

Peripheral Glucose Utilization and Peripheral Glucagon Release
Time frame · one year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· One year

Insulin Release Rate and Hepatic Glucose Release

Group	Value
Januvia	not posted
Placebo	not posted

Secondary and other outcome results(1)

Secondary outcome· one year

Peripheral Glucose Utilization and Peripheral Glucagon Release

Group	Value
Januvia	not posted
Placebo	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
JanuviaJanuvia: 1 tablet 100 mg once a day	–	0 / 0	0 / 0
PlaceboPlacebo: 1 tablet 100 mg once a day	–	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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) Exclusion Criteria: * Pregnant and/or lactating females * Women of childbearing potential not willing to use adequate contraception * Hct below inclusion criteria * 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

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