Effect of Renal Impairment on the Pharmacokinetics of NN9535 | NCT00833716

Studies
Effect of Renal Impairment on the Pharmacokinetics of NN9535

NCT00833716

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

62Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2
Renal Impairment

Interventions

semaglutide

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

No data available

No data is available for this block.

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2009Actual

Primary Completion Date

Jul 26, 2010Actual

Completion Date

Jul 26, 2010Actual

First Submitted Date

Jan 29, 2009

First Submission Date that Met QC Criteria

Jan 30, 2009

First Posted Date

Feb 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Mar 31, 2017

Last Update Posted Date

Apr 4, 2017Actual

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 trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: semaglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Drug	10 mg/mL of semaglutide solution for s.c. injection, single dose	A

Measure	Description	Time Frame
AUC of NN9535		at 21 days

Measure	Description	Time Frame
Laboratory safety, adverse events		at 21 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft & Gault formula) for any of the renal function groups
Body Mass Index (BMI) equal to or less than 40kg/m2

Exclusion Criteria:

Known or suspected allergy to trial product(s) or related products
Renal transplanted patients
Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months)
Known current hepatic dysfunction or severe hepatic disease during the last 12 months
Female of childbearing potential/breast feeding
History of alcoholism or drug abuse
Blood donation during the last 8 weeks prior to the study
Past or current history of pancreatitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Miami	Florida	33014	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Marbury T, Flint A, Segel S, Lindegaard M, Lasseter K. Pharmacokinetics and tolerability of semaglutide, a once-weekly human GLP-1 analog, in subjects with and without renal impairment. Diabetes 2014; 63 (Suppl 1): A260 (abstract 1010-P)
28349386	Result	Marbury TC, Flint A, Jacobsen JB, Derving Karsbol J, Lasseter K. Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. Clin Pharmacokinet. 2017 Nov;56(11):1381-1390. doi: 10.1007/s40262-017-0528-2.

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2
D051437	Renal Insufficiency

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases