DiabetesPhase 4NCT00676819
Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes
A Phase 4 study testing insulin aspart and human insulin 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 trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin aspart and human insulin
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jan 2002to 19 Jul 2002
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Type 2 diabetes
- Duration of diabetes for at least 12 months
- Current treatment with human insulin or insulin analogues for at least 6 months
- BMI equal to or below 35 kg/m2
- HbA1c equal to or greater than 10.0 %
- No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study
Who cannot join
- History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject
- Current treatment with systemic corticosteroids
- Any positive reaction of drug of abuse or alcohol screen
- Cardiac problems defined as: decompensated heart failure and/or angina pectoris
- Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure > 180 mm Hg systolic and/or > 110 mm Hg diastolic
- Known or suspected allergy to trial product or related products
- Blood donation of more than 500 ml within the last 12 weeks
- The receipt of any investigational drug within 4 weeks prior to this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus
This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin aspart, human insulin
- 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.
insulin aspartDrug
Also called ANA, NovoRapid
human insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose infusion rate
Measured: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))
Secondary outcomes (10)
AUCGIR(0-300 min) the area under the GIR profile
Measured: in the interval 0-300 minutes post dosing
AUCGIR(0 min-end of clamp) the area under the GIR profile
Measured: in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
AUCGIR(300min-end of clamp) the area under the GIR profile
Measured: in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
GIRmax: the maximal GIR value
Measured: tmax, GIR: the time to maximal GIR value
early and late t50%, GIR
Measured: the time to early and late half-maximal GIR value
AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile
Measured: in the interval 0-60 minutes post dosing
AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile
Measured: in the interval 0-300 minutes post dosing
AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile
Measured: in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile
Measured: in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study start10 Jan 2002
- Primary completion19 Jul 2002
- Study completion19 Jul 2002
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 19 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
- NCT00676819
- Sponsor's protocol ID
- ANA-1416
- Status last verified
- Mar 2017
- First submitted
- 9 May 2008
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Krones R, Schutte C, Heise T. The rapid-acting properties of insulin aspart are preserved in elderly people with type 2 diabetes. Diabetes Obes Metab. 2009 Jan;11(1):41-4. doi: 10.1111/j.1463-1326.2008.00988.x.
PubMed 19120432
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00676819
- Acronym / sponsor ID
- ANA-1416
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2002 (actual)
- Primary completion
- 19 Jul 2002 (actual)
- Study completion
- 19 Jul 2002 (actual)
- First posted
- 13 May 2008 (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 if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes
- Duration of diabetes for at least 12 months
- Current treatment with human insulin or insulin analogues for at least 6 months
- BMI equal to or below 35 kg/m2
- HbA1c equal to or greater than 10.0 %
Key exclusion criteria (8 listed)
- History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject
- Current treatment with systemic corticosteroids
- Any positive reaction of drug of abuse or alcohol screen
- Cardiac problems defined as: decompensated heart failure and/or angina pectoris
- Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure > 180 mm Hg systolic and/or > 110 mm Hg diastolic
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 aspartAlso: ANA, NovoRapid | Drug | – |
| human insulin | Drug | – |
Primary outcome
Glucose infusion rate
Time frame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))
10 secondary outcomes
AUCGIR(0-300 min) the area under the GIR profile
Time frame: in the interval 0-300 minutes post dosing
AUCGIR(0 min-end of clamp) the area under the GIR profile
Time frame: in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
AUCGIR(300min-end of clamp) the area under the GIR profile
Time frame: in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
GIRmax: the maximal GIR value
Time frame: tmax, GIR: the time to maximal GIR value
early and late t50%, GIR
Time frame: the time to early and late half-maximal GIR value
AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile
Time frame: in the interval 0-60 minutes post dosing
AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile
Time frame: in the interval 0-300 minutes post dosing
AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile
Time frame: in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile
Time frame: in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values)
Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration
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 Mar 2017.
- Results publication: PubMed 19120432Krones R, Schutte C, Heise T. The rapid-acting properties of insulin aspart are preserved in elderly people with type 2 diabetes. Diabetes Obes Metab. 2009 Jan;11(1):41-4. doi: 10.1111/j.1463-1326.2008.00988.x.
- 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 4 study testing insulin aspart and human insulin 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 6 inclusion and 8 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 Mar 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Glucose infusion rate (time frame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676819, 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 16 Mar 2017.