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Trial · Interventional

CompletedPhase 1Registry data

A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes

NCTNCT02147431 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3684Other id2013-002751-15Other idU1111-1144-7019
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
38 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Austria

Start
21 May 2014
Primary completion
20 May 2015
Completion
20 May 2015
First posted
26 May 2014 (estimated)
Last update posted
13 Aug 2018
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes

    NCT02147431

    21 May 2014 to 20 May 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Europe. The aim of this trial is to investigate the effect of semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2 diabetes.

Interventions

  • semaglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Semaglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))

    Time frame · After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Secondary outcomes(4)

  1. Change in mean glucagon concentration from target level 5.5 mmol/L to 3.5 mmoL/L and from ambient plasma glucose to target levels 5.5 mmol/L, 3.5 mmol/L and nadir

    Time frame · After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  2. Change in mean concentrations of adrenaline, noradrenaline, cortisol and growth hormone from target level 5.5 mmol/L to 3.5 mmol/L and to nadir

    Time frame · After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  3. Hypoglycaemic symptoms score

    Time frame · After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  4. Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L

    Time frame · After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

8 results

Effect of once-weekly semaglutide on the counterregulatory response to hypoglycaemia in people with type 2 diabetes: A randomized, placebo-controlled, double-blind, crossover trial.

Korsatko et al. 2018Diabetes, obesity & metabolismcited by 25

PMID 29893488PMC6221089DOI 10.1111/dom.13422PUB-29893488

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as unchanged dose * Male or female, age between18-64 years (both inclusive) at the time of signing informed consent * Body Mass Index (BMI) between 20.0-35.0 kg/m\^2 (both inclusive) * HbA1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive) Exclusion Criteria: * Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness * Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * Blood or plasma donation within the past month or more than 500 mL within the last 3 months prior to first semaglutide dosing

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