DiabetesPhase 1NCT01028404
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
A Phase 1 study testing NN1952 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes. The trial consists of two parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- NN1952 and insulin aspart
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jun 2010
- 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
- FOR TRIAL PART 1, THE FOLLOWING APPLIES:
- Gender: male
- Age: 18-55 years
- BMI (body mass index): 18-28 kg/m2
- Study participants considered to be healthy
- FOR TRIAL PART 2, THE FOLLOWING APPLIES:
Show all 13Show fewer
- Gender: male or female of no childbearing potential
- Age: 18-65 years
- Type 1 diabetes: BMI (body mass index): 18-28 kg/m2
- Type 2 diabetes: BMI (body mass index): 22-35 kg/m2
- Type 1 or type 2 diabetes for at least 12 months
- Type 1 diabetes: Treatment with insulin for at least 12 months
- Type 2 diabetes: Treatment with insulin for at least 3 months
Who cannot join
- Known or suspected allergy to the trial product or related products
- Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
- Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.
The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.
- Being tested
- NN1952, insulin aspart, placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NN1952Drug
Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.
insulin aspartDrug
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
placeboDrug
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
NN1952Drug
Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.
insulin aspartDrug
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.
placeboDrug
Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
| Study group | Role | What they receive |
|---|---|---|
| Trial part 1 | Experimental | Not described Receives: Drug: NN1952; Drug: insulin aspart; Drug: placebo |
| Trial part 2 | Experimental | Not described Receives: Drug: NN1952; Drug: insulin aspart; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse events for trial part 1
Measured: from visit 1 to visit 3
Number and severity of adverse events for trial part 2
Measured: from visit 1 to visit 6
Secondary outcomes (2)
Area under the serum insulin concentration-time curve after a single dose
Measured: after 12 hours
Area under the glucose infusion rate-time curve after a single dose
Measured: after 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 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
- NCT01028404
- Sponsor's protocol ID
- NN1952-3646
- Other IDs
- U1111-1112-2892, 2009-013282-26, 2009
- Status last verified
- Jul 2017
- First submitted
- 7 Dec 2009
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01028404
- Acronym / sponsor ID
- NN1952-3646
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Dec 2009 (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 safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.
The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial part 1 | Experimental | Drug: NN1952, Drug: insulin aspart, Drug: placebo |
| Trial part 2 | Experimental | Drug: NN1952, Drug: insulin aspart, Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- FOR TRIAL PART 1, THE FOLLOWING APPLIES:
- Gender: male
- Age: 18-55 years
- BMI (body mass index): 18-28 kg/m2
- Study participants considered to be healthy
Key exclusion criteria (3 listed)
- Known or suspected allergy to the trial product or related products
- Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
- Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
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 |
|---|---|---|
| NN1952Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation. | Drug | Trial part 1 |
| insulin aspartAs an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels. | Drug | Trial part 1 |
| placeboSubjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels. | Drug | Trial part 1 |
| NN1952Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1. | Drug | Trial part 2 |
| insulin aspartAs an active comparator, one standard dose will be given s.c. (under the skin) at one study visit. | Drug | Trial part 2 |
| placeboSubjects will receive a single dose of placebo as a comparator to NN1952 at one study visit. | Drug | Trial part 2 |
Primary outcome
Number and severity of adverse events for trial part 1
Time frame: from visit 1 to visit 3
Number and severity of adverse events for trial part 2
Time frame: from visit 1 to visit 6
2 secondary outcomes
Area under the serum insulin concentration-time curve after a single dose
Time frame: after 12 hours
Area under the glucose infusion rate-time curve after a single dose
Time frame: after 12 hours
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 25 Jul 2017.
- 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 NN1952 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site 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 13 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 25 Jul 2017. 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 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?
Number and severity of adverse events for trial part 1 (time frame: from visit 1 to visit 3). 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 25 Jul 2017.