DiabetesPhase 1NCT01730014
A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes
A Phase 1 study testing 148-0287-A-4.2mM-cartridge, insulin glargine and sodium chloride 0.9% w/v 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 safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Healthy
- What is being tested?
- 148-0287-A-4.2mM-cartridge, insulin glargine and sodium chloride 0.9% w/v
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Jul 2013
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- TRIAL PART 1 (HEALTHY SUBJECTS):
- Healthy male subject
- Age 18-55 years (both inclusive)
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
- TRIAL PART 2 (SUBJECTS WITH TYPE 1 DIABETES):
- Healthy male subject (with the exception of conditions associated with diabetes mellitus)
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- Age 18-64 years (both inclusive)
- Body mass index 18.0-28.0 kg/m^2 (both incl.)
- Type 1 diabetes mellitus (as diagnosed clinically) and treated with multiple daily insulin injections more than 12 months
- HbA1C (glycosylated haemoglobin) below or equal to 8.5 %
- Current daily basal insulin requirement above or equal to 0.2 to below or equal to 0.8 (I)U/kg/day and current total daily insulin treatment below 1.2 (I)U/kg/day
- Fasting C-peptide below 0.3 nmol/L
Who cannot join
- The receipt of any investigational medicinal product within the last 3 months prior to the start of this trial (screening)
- Significant blood loss (due to donation, surgery or trauma) of more than 500 mL within 3 months prior to the start of this trial (screening) or participating in any other trial involving blood sampling within the last 2 months before the start of this trial (screening)
- Use of any prescription (see specification below for Trial Part 2) or non-prescription medication, including herbal products and non-routine vitamins, within the last 2 weeks before the start of the trial (screening) that will interfere with the pharmacokinetics of insulin 287, as judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use of paracetamol is permitted up to 48 hours prior to dosing
- History of alcoholism or drug abuse (within the last 2 years), or positive result of alcohol or drug screening test
- Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco products) or smoking 1 cigarette or less per day and not considering being able to refrain from smoking or refrain from use of other types of nicotine products (e.g. such as chewing tobacco, nicotine gums) during the in-house periods
- Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator
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- Excessive consumption of a diet deviating from a normal diet as judged by the investigator
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation in the trial
- Vulnerable subjects (e.g. persons kept in detention)
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial
- ADDITIONAL KEY EXCLUSION CRITERIA TRIAL PART 2 (subjects with type 1 diabetes):
- Current treatment with statins, systemic (oral, intravenous or inhaled) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, thyroid hormones, growth hormone and other drugs, which may interfere with glucose metabolism
- Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator
- 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 past 6 months before start of this trial (screening)
- Cardiac problems defined as: decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time, or acute myocardial infarction at any time, or angina pectoris within the last 12 months before start of this trial (screening)
- Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0148-0000-0287 in Healthy Subjects and in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Healthy
- Being tested
- 148-0287-A-4.2mM-cartridge, placebo, insulin glargine, sodium chloride 0.9% w/v
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
148-0287-A-4.2mM-cartridgeDrug
In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
placeboDrug
In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
148-0287-A-4.2mM-cartridgeDrug
In a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
placeboDrug
In a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
insulin glargineDrug
In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
sodium chloride 0.9% w/vDrug
In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B.
| Study group | Role | What they receive |
|---|---|---|
| Trial part 1 | Experimental | Not described Receives: Drug: 148-0287-A-4.2mM-cartridge; Drug: placebo |
| Trial part 2, treatment A | Experimental | Not described Receives: Drug: 148-0287-A-4.2mM-cartridge; Drug: sodium chloride 0.9% w/v |
| Trial part 2, treatment B | Experimental | Not described Receives: Drug: placebo; Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE)
Measured: From trial product administration until completion of the post-treatment follow-up visit at Day 37
Secondary outcomes (9)
Incidence of hypoglycaemic episodes
Measured: From trial product administration until completion of the post-treatment follow-up visit at Day 37
AUC, the area under the serum insulin 287 concentration-time curve
Measured: From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points
Cmax, the maximum serum insulin 287 concentration
Measured: Observed (within 0-36 days)
tmax, the time for maximum serum insulin 287 concentration
Measured: Within 0-36 days
Average morning fasting blood glucose (FBG) concentration
Measured: From Day 2 to Day 8
Average morning fasting serum C-peptide concentration
Measured: From Day 2 to Day 8
Average morning fasting serum free fatty acid (FFA) concentration
Measured: From Day 2 to Day 8
Area under the glucose infusion rate (GIR)-time curve
Measured: At Day 1-2, 4-5, or 7-8
The maximal GIR (glucose infusion rate) observed
Measured: At Day 1-2, 4-5, or 7-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 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
- NCT01730014
- Sponsor's protocol ID
- NN1436-3955
- Other IDs
- 2011-005172-41, U1111-1125-2924
- Status last verified
- Jul 2013
- First submitted
- 6 Nov 2012
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. 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 Subcutaneous NNC0148-0000-0287 in Healthy Subjects and in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01730014
- Acronym / sponsor ID
- NN1436-3955
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Nov 2012 (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 safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trial part 1 | Experimental | Drug: 148-0287-A-4.2mM-cartridge, Drug: placebo |
| Trial part 2, treatment A | Experimental | Drug: 148-0287-A-4.2mM-cartridge, Drug: sodium chloride 0.9% w/v |
| Trial part 2, treatment B | Experimental | Drug: placebo, Drug: insulin glargine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- TRIAL PART 1 (HEALTHY SUBJECTS):
- Healthy male subject
- Age 18-55 years (both inclusive)
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
- TRIAL PART 2 (SUBJECTS WITH TYPE 1 DIABETES):
Key exclusion criteria (16 listed)
- The receipt of any investigational medicinal product within the last 3 months prior to the start of this trial (screening)
- Significant blood loss (due to donation, surgery or trauma) of more than 500 mL within 3 months prior to the start of this trial (screening) or participating in any other trial involving blood sampling within the last 2 months before the start of this trial (screening)
- Use of any prescription (see specification below for Trial Part 2) or non-prescription medication, including herbal products and non-routine vitamins, within the last 2 weeks before the start of the trial (screening) that will interfere with the pharmacokinetics of insulin 287, as judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use of paracetamol is permitted up to 48 hours prior to dosing
- History of alcoholism or drug abuse (within the last 2 years), or positive result of alcohol or drug screening test
- Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco products) or smoking 1 cigarette or less per day and not considering being able to refrain from smoking or refrain from use of other types of nicotine products (e.g. such as chewing tobacco, nicotine gums) during the in-house periods
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 |
|---|---|---|
| 148-0287-A-4.2mM-cartridgeIn a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously. | Drug | Trial part 1 |
| placeboIn a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously. | Drug | Trial part 1 |
| 148-0287-A-4.2mM-cartridgeIn a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B. | Drug | Trial part 2, treatment A |
| placeboIn a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B. | Drug | Trial part 2, treatment B |
| insulin glargineIn a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B. | Drug | Trial part 2, treatment B |
| sodium chloride 0.9% w/vIn a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B. | Drug | Trial part 2, treatment A |
Primary outcome
Incidence of adverse events (AE)
Time frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37
9 secondary outcomes
Incidence of hypoglycaemic episodes
Time frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37
AUC, the area under the serum insulin 287 concentration-time curve
Time frame: From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points
Cmax, the maximum serum insulin 287 concentration
Time frame: Observed (within 0-36 days)
tmax, the time for maximum serum insulin 287 concentration
Time frame: Within 0-36 days
Average morning fasting blood glucose (FBG) concentration
Time frame: From Day 2 to Day 8
Average morning fasting serum C-peptide concentration
Time frame: From Day 2 to Day 8
Average morning fasting serum free fatty acid (FFA) concentration
Time frame: From Day 2 to Day 8
Area under the glucose infusion rate (GIR)-time curve
Time frame: At Day 1-2, 4-5, or 7-8
The maximal GIR (glucose infusion rate) observed
Time frame: At Day 1-2, 4-5, or 7-8
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 31 Jul 2013.
- 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 148-0287-A-4.2mM-cartridge, insulin glargine and sodium chloride 0.9% w/v 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 12 inclusion and 16 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 31 Jul 2013. 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?
Incidence of adverse events (AE) (time frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37). 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 31 Jul 2013.