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CompletedNCT02014259Updated Apr 19, 2018

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

A Phase 1 interventional study of semaglutide in Diabetes, Diabetes Mellitus, Type 2 and Healthy, sponsored by Novo Nordisk A/S. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-19.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
71
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 71 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Subjects with renal impairment

    Drug: semaglutide

  • Active comparator
    Subjects with normal renal function

    Drug: semaglutide

Interventions

  • Drugsemaglutide

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

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What researchers measure

Primary outcomes

  1. Area under the semaglutide plasma concentration time curve

    Time frame: From time 0 to 24 hours after the 10th dosing

Secondary outcomes

  1. Maximum observed semaglutide plasma concentration

    Time frame: 0 to 24 hours after the 10th dosing

  2. 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

  3. Maximum observed SNAC plasma concentration

    Time frame: 0 to 24 hours after the 10th dosing

07

Study locations

4 sites
  • Novo Nordisk Investigational Site
    Hradec Králové, 50005, Czechia
  • Novo Nordisk Investigational Site
    Praha 7, 17000, Czechia
  • Novo Nordisk Investigational Site
    Budapest, 1076, Hungary
  • Novo Nordisk Investigational Site
    Budapest, 1115, Hungary
08

References and documents

Publications

  • 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. PubMed 29623579 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02014259
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 18, 2013
Start date
Dec 11, 2013
Primary completion
Oct 24, 2014
Completion
Oct 24, 2014
Last update
Apr 19, 2018

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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