Diabetes Mellitus, Type 2Phase 1NCT03598621
A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
A Phase 1 study testing Semaglutide, 0.5 mg/mL, Semaglutide, 1.0 mg/mL and Semaglutide, 1.34 mg/mL in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Germany.
Trial summary
This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide, 0.5 mg/mL, Semaglutide, 1.0 mg/mL and Semaglutide, 1.34 mg/mL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesGermany
- Study dates
- 23 Jul 2018to 17 Jan 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prior to the day of screening.
- Abuse or intake of alcohol, defined as any of the below: a) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women. b) Positive alcohol test at screening.
- Abuse or intake of drugs, defined as any of the below: a) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening. b) Positive drug of abuse test at screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Neuss, 41460
About this study
Official title: A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device and the Formulation for the PDS290 Semaglutide Pen-injector
This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide, 0.5 mg/mL, Semaglutide, 1.0 mg/mL, Semaglutide, 1.34 mg/mL, Semaglutide, 2.0 mg/mL, DV3372, 0.5 mg/mL
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide, 0.5 mg/mLDrug
A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.0 mg/mLDrug
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.34 mg/mLDrug
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 2.0 mg/mLDrug
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DV3372, 0.5 mg/mLDevice
DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
DV3372, 1.0 mg/mLDevice
DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
PDS290Device
PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
NovoPen®4Device
NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Semaglutide 0.25 mg | Experimental | Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. Receives: Drug: Semaglutide, 0.5 mg/mL; Drug: Semaglutide, 1.34 mg/mL; Device: DV3372, 0.5 mg/mL; Device: PDS290 |
| Cohort 2: Semaglutide 0.5 mg | Experimental | Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. Receives: Drug: Semaglutide, 1.0 mg/mL; Drug: Semaglutide, 1.34 mg/mL; Device: DV3372, 1.0 mg/mL; Device: PDS290 |
| Cohort 3: Semaglutide 0.5 mg | Experimental | Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. Receives: Drug: Semaglutide, 1.34 mg/mL; Drug: Semaglutide, 2.0 mg/mL; Device: PDS290; Device: NovoPen®4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration
Measured in nmol·h/L.
Measured: 0-840 hours (5 weeks)
Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration
Measured in nmol/L.
Measured: 0-840 hours (5 weeks)
Secondary outcomes (7)
AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration
Measured in nmol·h/L.
Measured: 0-840 hours (5 weeks)
tmax,sema,SD, time to Cmax,sema,SD of semaglutide
Measured in hours.
Measured: 0-840 hours (5 weeks)
t½,sema,SD, terminal elimination half-life of semaglutide
Measured in hours.
Measured: 0-840 hours (5 weeks)
Cl/F,sema,SD, total apparent clearance of semaglutide
Measured in L/h.
Measured: 0-840 hours (5 weeks)
Vz/F,sema,SD, apparent volume of distribution of semaglutide
Measured in L.
Measured: 0-840 hours (5 weeks)
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Count of technical complaints.
Measured: Week 0-5 in both treatment period 1 and 2
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Count of technical complaints.
Measured: Week 0-5 in both treatment period 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start23 Jul 2018
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598621
- Sponsor's protocol ID
- NN9535-4387
- Other IDs
- U1111-1200-8075, 2017-003437-29, 2017
- Status last verified
- Jan 2020
- First submitted
- 16 Jul 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device and the Formulation for the PDS290 Semaglutide Pen-injector
- ClinicalTrials.gov ID
- NCT03598621
- Acronym / sponsor ID
- NN9535-4387
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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 study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Semaglutide 0.25 mg | Experimental | Drug: Semaglutide, 0.5 mg/mL, Drug: Semaglutide, 1.34 mg/mL, Device: DV3372, 0.5 mg/mL, Device: PDS290Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. |
| Cohort 2: Semaglutide 0.5 mg | Experimental | Drug: Semaglutide, 1.0 mg/mL, Drug: Semaglutide, 1.34 mg/mL, Device: DV3372, 1.0 mg/mL, Device: PDS290Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. |
| Cohort 3: Semaglutide 0.5 mg | Experimental | Drug: Semaglutide, 1.34 mg/mL, Drug: Semaglutide, 2.0 mg/mL, Device: PDS290, Device: NovoPen®4Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (5 listed)
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prior to the day of screening.
- Abuse or intake of alcohol, defined as any of the below: a) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women. b) Positive alcohol test at screening.
- Abuse or intake of drugs, defined as any of the below: a) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening. b) Positive drug of abuse test at screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.
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 |
|---|---|---|
| Semaglutide, 0.5 mg/mLA single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours. | Drug | Cohort 1: Semaglutide 0.25 mg |
| Semaglutide, 1.0 mg/mLA single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours. | Drug | Cohort 2: Semaglutide 0.5 mg |
| Semaglutide, 1.34 mg/mLA single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours. | Drug | Cohort 1: Semaglutide 0.25 mg, Cohort 2: Semaglutide 0.5 mg, Cohort 3: Semaglutide 0.5 mg |
| Semaglutide, 2.0 mg/mLA single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours. | Drug | Cohort 3: Semaglutide 0.5 mg |
| DV3372, 0.5 mg/mLDV3372 device will be used for administration of semaglutide 0.5 mg/mL. | Device | Cohort 1: Semaglutide 0.25 mg |
| DV3372, 1.0 mg/mLDV3372 device will be used for administration of semaglutide 1.0 mg/mL. | Device | Cohort 2: Semaglutide 0.5 mg |
| PDS290PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL. | Device | Cohort 1: Semaglutide 0.25 mg, Cohort 2: Semaglutide 0.5 mg, Cohort 3: Semaglutide 0.5 mg |
| NovoPen®4NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL. | Device | Cohort 3: Semaglutide 0.5 mg |
Primary outcome
AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration
Time frame: 0-840 hours (5 weeks)
Measured in nmol·h/L.
Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration
Time frame: 0-840 hours (5 weeks)
Measured in nmol/L.
7 secondary outcomes
AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration
Time frame: 0-840 hours (5 weeks)
tmax,sema,SD, time to Cmax,sema,SD of semaglutide
Time frame: 0-840 hours (5 weeks)
t½,sema,SD, terminal elimination half-life of semaglutide
Time frame: 0-840 hours (5 weeks)
Cl/F,sema,SD, total apparent clearance of semaglutide
Time frame: 0-840 hours (5 weeks)
Vz/F,sema,SD, apparent volume of distribution of semaglutide
Time frame: 0-840 hours (5 weeks)
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Time frame: Week 0-5 in both treatment period 1 and 2
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Time frame: Week 0-5 in both treatment period 1 and 2
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 9 Jan 2020.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
2 sites 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, 0.5 mg/mL, Semaglutide, 1.0 mg/mL and Semaglutide, 1.34 mg/mL in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Germany.
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 3 inclusion and 5 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. 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?
AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration (time frame: 0-840 hours (5 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2020.