NCT02014259

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Dec 2013

Typical duration for phase_1 diabetes

Geographic Reach
2 countries

4 active sites

Status
completed

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

December 11, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2014

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

December 12, 2013

Last Update Submit

April 17, 2018

Conditions

DiabetesDiabetes Mellitus, Type 2Healthy

Outcome Measures

Primary Outcomes (1)

  • Area under the semaglutide plasma concentration time curve

    From time 0 to 24 hours after the 10th dosing

Secondary Outcomes (3)

  • Maximum observed semaglutide plasma concentration

    0 to 24 hours after the 10th dosing

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

    From time 0 to 24 hours after the 10th dosing

  • Maximum observed SNAC plasma concentration

    0 to 24 hours after the 10th dosing

Study Arms (2)

Subjects with renal impairment

EXPERIMENTAL
Drug: semaglutide

Subjects with normal renal function

ACTIVE COMPARATOR
Drug: semaglutide

Interventions

semaglutideDRUG

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

Subjects with normal renal functionSubjects with renal impairment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novo Nordisk Investigational Site

Hradec Králové, 50005, Czechia

Location

Novo Nordisk Investigational Site

Prague, 17000, Czechia

Location

Novo Nordisk Investigational Site

Budapest, 1076, Hungary

Location

Novo Nordisk Investigational Site

Budapest, 1115, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 29623579RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 18, 2013

Study Start

December 11, 2013

Primary Completion

October 24, 2014

Study Completion

October 24, 2014

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

HU(2)CZ(2)