DiabetesPhase 1NCT01538511
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers
A Phase 1 study testing biphasic insulin aspart 70 and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart 70 and biphasic insulin aspart 30
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteJapan
- Study dates
- 5 Jun 2006to 13 Mar 2007
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SUBJECTS WITH TYPE 2 DIABETES
- Subjects with type 2 diabetes mellitus
- Current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use [maximum of one week in total] of rapid-acting human insulin will be allowed)
- Age between 20-69 years, both inclusive
- HbA1c (glycosylated haemoglobin A1c) below 9.0%
- Body Mass Index (BMI) 18.5-25.0 kg/m^2
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- Total daily insulin dose (per day) above 0.2 U or IU/kg body weight and below 1.0 U or IU/kg body weight HEALTHY VOLUNTEERS
- Japanese subjects with considered generally healthy based on medical history and physical examination
- Age between 20-29 years, both inclusive
- Body Mass Index (BMI) 18.5-25.0 kg/m^2
- Subjects with normal glucose tolerance (NGT); defined as fasting plasma glucose below 110 mg/dL and 2-hour post OGTT (oral glucose tolerance test) plasma glucose below 140 mg/dL
Who cannot join
- SUBJECTS WITH TYPE 2 DIABETES
- Proliferative retinopathy or maculopathy requiring acute treatment
- Impaired hepatic function
- Impaired renal function
- Serious cardiac diseases
- Uncontrolled hypertension
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- Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- Current treatment or expected at the screening to start treatment with systemic corticosteroids HEALTHY VOLUNTEERS
- Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) at the screening
- History or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- Subjects with a first-degree relative with diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-centre, Randomised, Open-labelled, Four-week, Parallel-group Pharmacokinetics Trial in Japanese Type 2 Diabetic Subjects Characterising the Insulin Profile of Thrice Daily Regimen With Biphasic Insulin Aspart 70 (NN2000-Mix70) With Reference to That of Twice Daily Regimen With Biphasic Insulin Aspart 30 (NN-X14Mix30) and Physiological Insulin Profile in Japanese Healthy Volunteers
This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 70, biphasic insulin aspart 30
- 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.
biphasic insulin aspart 70Drug
Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted
biphasic insulin aspart 30Drug
Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 70 | Experimental | Not described Receives: Drug: biphasic insulin aspart 70 |
| BIAsp 30 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma insulin concentration curve from 0 to 24 hours
Secondary outcomes (12)
Area under the concentration curve of plasma insulin from 0 to 4 hours after meals
Maximum plasma insulin concentration observed from 0 to 4 hours after meals
Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals
The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects
Pre-meal plasma glucose concentration before meals
Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals
The maximum plasma glucose concentration observed from 0 to 4 hours after meals
The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals
Average of plasma glucose concentration from 0 to 24 hours
The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile
Frequency of hypoglycaemic episodes
Frequency of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study start5 Jun 2006
- Primary completion13 Mar 2007
- Study completion13 Mar 2007
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
- None (open label)
- Enrolment
- 59 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
- NCT01538511
- Sponsor's protocol ID
- BIASP-1638
- Status last verified
- Oct 2017
- First submitted
- 20 Feb 2012
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-centre, Randomised, Open-labelled, Four-week, Parallel-group Pharmacokinetics Trial in Japanese Type 2 Diabetic Subjects Characterising the Insulin Profile of Thrice Daily Regimen With Biphasic Insulin Aspart 70 (NN2000-Mix70) With Reference to That of Twice Daily Regimen With Biphasic Insulin Aspart 30 (NN-X14Mix30) and Physiological Insulin Profile in Japanese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01538511
- Acronym / sponsor ID
- BIASP-1638
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2006 (actual)
- Primary completion
- 13 Mar 2007 (actual)
- Study completion
- 13 Mar 2007 (actual)
- First posted
- 24 Feb 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 Japan. The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIAsp 70 | Experimental | Drug: biphasic insulin aspart 70 |
| BIAsp 30 | Experimental | Drug: biphasic insulin aspart 30 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- SUBJECTS WITH TYPE 2 DIABETES
- Subjects with type 2 diabetes mellitus
- Current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use [maximum of one week in total] of rapid-acting human insulin will be allowed)
- Age between 20-69 years, both inclusive
- HbA1c (glycosylated haemoglobin A1c) below 9.0%
Key exclusion criteria (11 listed)
- SUBJECTS WITH TYPE 2 DIABETES
- Proliferative retinopathy or maculopathy requiring acute treatment
- Impaired hepatic function
- Impaired renal function
- Serious cardiac diseases
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 |
|---|---|---|
| biphasic insulin aspart 70Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted | Drug | BIAsp 70 |
| biphasic insulin aspart 30Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted | Drug | BIAsp 30 |
Primary outcome
Area under the plasma insulin concentration curve from 0 to 24 hours
12 secondary outcomes
Area under the concentration curve of plasma insulin from 0 to 4 hours after meals
Maximum plasma insulin concentration observed from 0 to 4 hours after meals
Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals
The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects
Pre-meal plasma glucose concentration before meals
Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals
The maximum plasma glucose concentration observed from 0 to 4 hours after meals
The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals
Average of plasma glucose concentration from 0 to 24 hours
The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile
Frequency of hypoglycaemic episodes
Frequency of adverse events
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 6 Oct 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 biphasic insulin aspart 70 and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, 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 11 inclusion and 11 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 6 Oct 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 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?
Area under the plasma insulin concentration curve from 0 to 24 hours. 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 6 Oct 2017.