Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptid... | NCT00947011

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

NCT00947011

Sponsor

Johns Hopkins University

Status

Terminated

Last Update Posted

Jul 12, 2017Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Glucose Homeostasis

Interventions

Placebo
Januvia

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left JHU

Expanded Access Info

Start Date

Mar 2009Actual

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

May 1, 2017

Results First Submitted that Met QC Criteria

Jun 29, 2017

Results First Posted Date

Jul 12, 2017Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2017

Last Update Posted Date

Jul 12, 2017Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of the present proposal is to 1) examine the role of dipeptidyl peptidase (DPP-4) inhibition on insulin release during a hyperglycemic clamp while GLP-1 is being infused and, 2) further elucidate the role of the metabolite of GLP-1, that is GLP-1 9-36 amide (GLP-1m). During stable and very reproducible elevated plasma glucose levels the effect of increased active incretin levels with DPP-4 inhibitors should result in increased plasma insulin levels. Therefore the aim of this protocol is to document whether plasma insulin levels are increased following GLP-1 infusion in the presence or absence of DPP-4 inhibitors. Additionally, the investigators have shown that some improvement in glucose homeostasis during GLP-1 administration is due in part to the metabolite of GLP-1, i.e. GLP-1 (9-36) amide (GLP-1m). Therefore, the investigators will also test the role of the latter by infusing GLP-1m when the volunteers are being treated with DPP-4 inhibitors.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Januvia	Active Comparator		Drug: Januvia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	1 tablet 100 mg once a day	Placebo	Sugar pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin Release Rate and Hepatic Glucose Release		One year

Secondary Outcomes

Measure	Description	Time Frame
Peripheral Glucose Utilization and Peripheral Glucagon Release		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dariush Elahi, PhD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Bayview Medical Center		Baltimore	Maryland	21224	United States

ID	Title	Description
FG000	All Participants	Januvia: 1 tablet 100 mg once a day OR Placebo comparator

Baseline Characteristics Module

Baseline Analysis Population Description

Although 12 participants were enrolled in this study, their assignment to a specific Arm/Group is unknown, as the PI has left the institution and no further data (if any) is available.

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	All Particpants	Januvia: 1 tablet 100 mg once a day OR Placebo: 1 tablet 100 mg once a day

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Number

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Insulin Release Rate and Hepatic Glucose Release

Data was not collected for this outcome measure. The study was terminated. The P.I. left the institution.

Posted

One year

ID	Title	Description
OG000	Januvia	Januvia: 1 tablet 100 mg once a day
OG001	Placebo	Placebo: 1 tablet 100 mg once a day

Units	Counts
Participants

Adverse Events Module

Frequency Threshold

Time Frame

This study was prematurely terminated because the P.I. left the institution. The time frame for Adverse Event data (if collected) is unknown.

Description

This study was prematurely terminated because the P.I. left the institution. The data for Adverse Events, if collected, is unknown.

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Januvia	Januvia: 1 tablet 100 mg once a day

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Yes

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Johns Hopkins University Clinical Trials Program	Johns Hopkins University School of Medicine	410-550-6484		registerclinicaltrials@jhmi.edu

Intervention Browse Module

MeSH Terms

ID	Term
D000073893	Sugars
D000068900	Sitagliptin Phosphate

Ancestor Terms

ID	Term
D002241	Carbohydrates
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided