DiabetesPhase 1NCT02147431
A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes
A Phase 1 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteAustria
- Study dates
- 21 May 2014to 20 May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-centre, Double-blind, Cross-over Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counter-regulation Compared to Placebo in Subjects With Type 2 Diabetes
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- semaglutide, placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide.
Each treatment period will be followed by a hypoglycaemic clamp
placeboDrug
2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection.
Each treatment period will be followed by a hypoglycaemic clamp.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Not described Receives: Drug: semaglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))
Measured: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Secondary outcomes (4)
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
Measured: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
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
Measured: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Hypoglycaemic symptoms score
Measured: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L
Measured: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study start21 May 2014
- Primary completion20 May 2015
- Study completion20 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147431
- Sponsor's protocol ID
- NN9535-3684
- Other IDs
- 2013-002751-15, U1111-1144-7019
- Status last verified
- Aug 2018
- First submitted
- 21 May 2014
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Korsatko S, Jensen L, Brunner M, Sach-Friedl S, Tarp MD, Holst AG, Heller SR, Pieber TR. 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. Diabetes Obes Metab. 2018 Nov;20(11):2565-2573. doi: 10.1111/dom.13422. Epub 2018 Jul 16.
PubMed 29893488
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-centre, Double-blind, Cross-over Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counter-regulation Compared to Placebo in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02147431
- Acronym / sponsor ID
- NN9535-3684
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 May 2014 (actual)
- Primary completion
- 20 May 2015 (actual)
- Study completion
- 20 May 2015 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: semaglutide |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutide2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide. Each treatment period will be followed by a hypoglycaemic clamp | Drug | Semaglutide |
| placebo2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection. Each treatment period will be followed by a hypoglycaemic clamp. | Drug | Placebo |
Primary outcome
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)
4 secondary outcomes
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)
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)
Hypoglycaemic symptoms score
Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Results publication: PubMed 29893488Korsatko S, Jensen L, Brunner M, Sach-Friedl S, Tarp MD, Holst AG, Heller SR, Pieber TR. 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. Diabetes Obes Metab. 2018 Nov;20(11):2565-2573. doi: 10.1111/dom.13422. Epub 2018 Jul 16.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.