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Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2, Healthy

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

semaglutide

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female aged 18-85 years (both inclusive) at the time of signing inform consent
Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
For subject with normal renal function: good general health (as judged by the investigator)
Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)

Exclusion Criteria:

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2)
History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

Sites / Locations

Novo Nordisk Investigational Site
Novo Nordisk Investigational Site
Novo Nordisk Investigational Site
Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subjects with renal impairment

Subjects with normal renal function

Arm Description

Outcomes

Primary Outcome Measures

Area under the semaglutide plasma concentration time curve

Secondary Outcome Measures

Maximum observed semaglutide plasma concentration

Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve

Maximum observed SNAC plasma concentration

Full Information

NCT ID

NCT02014259

First Posted

December 12, 2013

Last Updated

April 17, 2018

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02014259

Brief Title

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

Official Title

Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

December 11, 2013 (Actual)

Primary Completion Date

October 24, 2014 (Actual)

Study Completion Date

October 24, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired renal function compared to subjects with normal renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects with renal impairment

Arm Type

Experimental

Arm Title

Subjects with normal renal function

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

semaglutide

Intervention Description

Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg

Primary Outcome Measure Information:

Title

Area under the semaglutide plasma concentration time curve

Time Frame

From time 0 to 24 hours after the 10th dosing

Secondary Outcome Measure Information:

Title

Maximum observed semaglutide plasma concentration

Time Frame

0 to 24 hours after the 10th dosing

Title

Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve

Time Frame

From time 0 to 24 hours after the 10th dosing

Title

Maximum observed SNAC plasma concentration

Time Frame

0 to 24 hours after the 10th dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 18-85 years (both inclusive) at the time of signing inform consent Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis) For subject with normal renal function: good general health (as judged by the investigator) Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive) Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg) Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2) History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Hradec Králové

ZIP/Postal Code

50005

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 7

ZIP/Postal Code

17000

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1076

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

12. IPD Sharing Statement

Citations:

PubMed Identifier

29623579

Citation

Granhall C, Sondergaard FL, Thomsen M, Anderson TW. Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment. Clin Pharmacokinet. 2018 Dec;57(12):1571-1580. doi: 10.1007/s40262-018-0649-2.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

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