DiabetesPhase 1NCT00825253
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 Diabetes
A Phase 1 study testing biphasic insulin aspart 30 and biphasic human insulin 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period) and the pharmacokinetics (i.e. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- biphasic insulin aspart 30 and biphasic human insulin 30
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
- Type 2 diabetes mellitus diagnosed for at least 12 months prior to screening
- HbA1c value between 7% and 10.5% (both inclusive) at screening
- Any insulin treatment for at least 3 months prior to screening
- Body mass index (BMI): 25 - 40 kg/m2
Who cannot join
- Use of any oral antidiabetic agent within the past 6 months
- Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
- Cardiac disease: NYHA class III or IV chronic heart failure (CHF), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
- Hepatic insufficiency (ALT or AST greater than or equal to 2 times the central laboratory's upper reference limit)
- Renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dL for males; greater than or equal to
- Recurrent hypoglycaemia or hypoglycaemic unawareness
Show all 12Show fewer
- Anaemia (haemoglobin less than 13.0 mg/dL in males and less than 12.0 mg/dL in females) (WHO criteria)
- Use of any systemic or topical medications (prescribed or non-prescribed) which may alter glucose metabolism (other than insulin products), including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
- History of substance (e.g. drugs, alcohol) abuse or a positive result in the urine drug/alcohol screen or consumption of more than 14 units (women) or 21 units (men) of alcohol per week (One unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits)
- Smoking of more than 20 cigarettes per day and inability to refrain from smoking during the in-house period
- Known hepatitis or positive serological tests for the hepatitis B surface antigen (HBsAg) or hepatitis C antibodies or HIV antibodies
- Uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 160 mmHg and/or diastolic blood pressure greater than or equal to 95 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-labelled, 4-period Crossover Trial Characterising Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 Administered Once, Twice or Thrice Daily and Biphasic Human Insulin 30 Administered Once Daily in Subjects With Type 2 Diabetes
This trial is conducted in Europe. The aim of this clinical trial is to compare the pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period) and the pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily and biphasic human insulin 30 administered once daily in type 2 diabetic subjects
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30, biphasic human insulin 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 30Drug
biphasic human insulin 30Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startMar 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 24 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
- NCT00825253
- Sponsor's protocol ID
- BIASP-1831
- Other IDs
- 2006-005958-75
- Status last verified
- Jan 2017
- First submitted
- 14 Jan 2009
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Heise T, Heinemann L, Hovelmann U, Brauns B, Nosek L, Haahr HL, Olsen KJ. Biphasic insulin aspart 30/70: pharmacokinetics and pharmacodynamics compared with once-daily biphasic human insulin and Basal-bolus therapy. Diabetes Care. 2009 Aug;32(8):1431-3. doi: 10.2337/dc09-0097. Epub 2009 Jun 1.
PubMed 19487640
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-labelled, 4-period Crossover Trial Characterising Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 Administered Once, Twice or Thrice Daily and Biphasic Human Insulin 30 Administered Once Daily in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00825253
- Acronym / sponsor ID
- BIASP-1831
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 19 Jan 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 clinical trial is to compare the pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period) and the pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily and biphasic human insulin 30 administered once daily in type 2 diabetic subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
- Type 2 diabetes mellitus diagnosed for at least 12 months prior to screening
- HbA1c value between 7% and 10.5% (both inclusive) at screening
- Any insulin treatment for at least 3 months prior to screening
- Body mass index (BMI): 25 - 40 kg/m2
Key exclusion criteria (12 listed)
- Use of any oral antidiabetic agent within the past 6 months
- Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
- Cardiac disease: NYHA class III or IV chronic heart failure (CHF), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
- Hepatic insufficiency (ALT or AST greater than or equal to 2 times the central laboratory's upper reference limit)
- Renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dL for males; greater than or equal to
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 30 | Drug | – |
| biphasic human insulin 30 | Drug | – |
Primary outcome
Not reported in the source record.
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 Jan 2017.
- Results publication: PubMed 19487640Heise T, Heinemann L, Hovelmann U, Brauns B, Nosek L, Haahr HL, Olsen KJ. Biphasic insulin aspart 30/70: pharmacokinetics and pharmacodynamics compared with once-daily biphasic human insulin and Basal-bolus therapy. Diabetes Care. 2009 Aug;32(8):1431-3. doi: 10.2337/dc09-0097. Epub 2009 Jun 1.
- 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 30 and biphasic human insulin 30 in people with Diabetes and Diabetes Mellitus, Type 2, 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 5 inclusion and 12 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 Jan 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825253, which also lists 1 linked publication.
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 Jan 2017.