DiabetesPhase 1NCT01269606
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
A Phase 1 study testing insulin aspart and insulin human in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin aspart and insulin human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2011to Mar 2011
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Treated with multiple daily insulin injections for at least 12 months
- Current daily basal insulin requirement above or equal to 0.3 U/kg/day
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0%
- Body Mass Index (BMI) 18.0-28.0 kg/m^2
Who cannot join
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening)
- Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening)
- Subject who smokes more than 10 cigarettes or the equivalent per day
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus
This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin aspart, insulin human
- 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.
insulin aspartDrug
At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
insulin humanDrug
At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
insulin aspartDrug
At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
insulin humanDrug
At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 - IM treatment group | Experimental | Not described Receives: Drug: insulin aspart |
| Treatment sequence 2 - IM treatment group | Experimental | Not described Receives: Drug: insulin human |
| Treatment sequence 1 - IV treatment group | Experimental | Not described Receives: Drug: insulin aspart |
| Treatment sequence 2 - IV treatment group | Experimental | Not described Receives: Drug: insulin human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance at steady state (CLss) for IV treatment group
Measured: from 180 min to 240 min
Area under the curve (AUC) for IM treatment group
Measured: from 0 to 480 min after intramuscular injection
Secondary outcomes (4)
Area under the curve (AUC) for IM treatment group
Measured: from 0 minutes to infinite time after intramuscular injection
Steady state concentration (Css) for IV treatment group
Measured: from 180 min to 240 min
Hypoglycaemic episodes
Measured: from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)
Adverse Events (AEs)
Measured: from first trial related activity to follow-up visit (2-21 days after last trial product administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT01269606
- Sponsor's protocol ID
- ANA-3877
- Other IDs
- U1111-1117-1353, JapicCTI-111383
- Status last verified
- Jun 2014
- First submitted
- 3 Jan 2011
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01269606
- Acronym / sponsor ID
- ANA-3877
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Jan 2011 (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 Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 - IM treatment group | Experimental | Drug: insulin aspart |
| Treatment sequence 2 - IM treatment group | Experimental | Drug: insulin human |
| Treatment sequence 1 - IV treatment group | Experimental | Drug: insulin aspart |
| Treatment sequence 2 - IV treatment group | Experimental | Drug: insulin human |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Treated with multiple daily insulin injections for at least 12 months
- Current daily basal insulin requirement above or equal to 0.3 U/kg/day
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0%
- Body Mass Index (BMI) 18.0-28.0 kg/m^2
Key exclusion criteria (4 listed)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening)
- Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening)
- Subject who smokes more than 10 cigarettes or the equivalent per day
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
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 |
|---|---|---|
| insulin aspartAt the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits. | Drug | Treatment sequence 1 - IM treatment group |
| insulin humanAt the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods. | Drug | Treatment sequence 2 - IM treatment group |
| insulin aspartAt the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits. | Drug | Treatment sequence 1 - IV treatment group |
| insulin humanAt the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods. | Drug | Treatment sequence 2 - IV treatment group |
Primary outcome
Clearance at steady state (CLss) for IV treatment group
Time frame: from 180 min to 240 min
Area under the curve (AUC) for IM treatment group
Time frame: from 0 to 480 min after intramuscular injection
4 secondary outcomes
Area under the curve (AUC) for IM treatment group
Time frame: from 0 minutes to infinite time after intramuscular injection
Steady state concentration (Css) for IV treatment group
Time frame: from 180 min to 240 min
Hypoglycaemic episodes
Time frame: from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)
Adverse Events (AEs)
Time frame: from first trial related activity to follow-up visit (2-21 days after last trial product administration)
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 16 Jun 2014.
- 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 insulin aspart and insulin human in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.
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 5 inclusion and 4 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 16 Jun 2014. 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 Japan. 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?
Clearance at steady state (CLss) for IV treatment group (time frame: from 180 min to 240 min). 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 16 Jun 2014.