Type 2 DiabetesPhase 4HUCKEPACK2NCT01293396
Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
A Phase 4 study testing Insulin Aspart, Insulin Aspart 30 and Insulin Aspart 70 in people with Type 2 Diabetes, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin Aspart, Insulin Aspart 30 and Insulin Aspart 70
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Mar 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type-II Diabetes
- BMI > 27 kg/m2
- age 35 to 75 years
- HbA1c < 8.5%
- informed consent
- treatment with pre-mixed insulin
- stabile dose of insulin for at least 4 weeks
Who cannot join
- Type-I Diabetes mellitus
- HbA1c > 8.5 %
- Serum Creatinine > 1.7 mg/dl
- Alaninaminotranferase or Aspartataminotransferase > 3x Upper Limit of Normal
- treatment with sulfonylurea or gliptins
- treatment with glitazones
Show all 12Show fewer
- manifest clinical infections
- treatment with glucocorticoids or antipsychotic drugs
- psychiatric diseases
- alcohol abuse
- myocardial infarction or stroke within the previous 3 months
- surgery within the previous 3 months
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department for Internal Medicine
Graz, 8036
About this study
Official title: Comparison of the Impact of Biphasic Insulin Aspart 30 (BiAsp 30), Biphasic Insulin Aspart 70 (BiAsp 70) and Insulin Aspart on Postprandial Glucose and Lipid Metabolism During Two Consecutive Meals in Type 2 Diabetics.
The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.
Read the detailed description
Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.
- Conditions
- Type 2 Diabetes
- Being tested
- Insulin Aspart, Insulin Aspart 30, Insulin Aspart 70
- Keywords
- insulin aspart 30, insulin aspart 70, insulin aspart, postprandial glucose and lipid metabolism, consecutive mixed meals
- Medical subject headings
- 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 Novorapid
Patients received insulin aspart before breakfast and before lunch.
Insulin Aspart 30Drug
Also called Novomix 30
Patients received biphasic insulin aspart 30 before breakfast and before lunch.
Insulin Aspart 70Drug
Also called Novomix 70
Patients received biphasic insulin aspart 70 before breakfast and before lunch.
| Study group | Role | What they receive |
|---|---|---|
| Biphasic Insulin Aspart 30 | Active comparator | 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch Receives: Drug: Insulin Aspart 30 |
| Biphasic Insulin Aspart 70 | Active comparator | 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch Receives: Drug: Insulin Aspart 70 |
| Insulin Aspart | Active comparator | 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch Receives: Drug: Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Over Basal for Postprandial Glucose From 0 to 600min
Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Measured: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area Over Basal for Postprandial Triglycerides
Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Measured: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Secondary outcomes (4)
Maximum Glucose Increase
Maximum glucose increase from baseline to 600min after baseline
Measured: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Maximum Triglyceride Increase
Maximum trigylceride increase from Baseline to 600min after Baseline
Measured: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area Over Basal for Postprandial Insulin
Area over basal for postprandial insulin from 0 (Fasting insulin, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Measured: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area Over Basal for Postprandial C-peptide
Area over basal for postprandial c-peptide from 0 (Fasting c-peptide, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Measured: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harald Sourij, MD, Principal investigator, Medical University of Graz, 8036 Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293396
- Sponsor's protocol ID
- ENM-DA-008
- Other IDs
- 2008-008486-35, 2008
- Acronym
- HUCKEPACK2
- Status last verified
- Jun 2021
- First submitted
- 9 Feb 2011
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impact of Biphasic Insulin Aspart 30 (BiAsp 30), Biphasic Insulin Aspart 70 (BiAsp 70) and Insulin Aspart on Postprandial Glucose and Lipid Metabolism During Two Consecutive Meals in Type 2 Diabetics.
- ClinicalTrials.gov ID
- NCT01293396
- Acronym / sponsor ID
- HUCKEPACK2 / ENM-DA-008
- Conditions
- Type 2 Diabetes
- Keywords
- insulin aspart 30, insulin aspart 70, insulin aspart, postprandial glucose and lipid metabolism, consecutive mixed meals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.
Detailed description
Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biphasic Insulin Aspart 30 | Active comparator | Drug: Insulin Aspart 3035% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch |
| Biphasic Insulin Aspart 70 | Active comparator | Drug: Insulin Aspart 7035% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch |
| Insulin Aspart | Active comparator | Drug: Insulin Aspart35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type-II Diabetes
- BMI > 27 kg/m2
- age 35 to 75 years
- HbA1c < 8.5%
- informed consent
Key exclusion criteria (12 listed)
- Type-I Diabetes mellitus
- HbA1c > 8.5 %
- Serum Creatinine > 1.7 mg/dl
- Alaninaminotranferase or Aspartataminotransferase > 3x Upper Limit of Normal
- treatment with sulfonylurea or gliptins
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: NovorapidPatients received insulin aspart before breakfast and before lunch. | Drug | Insulin Aspart |
| Insulin Aspart 30Also: Novomix 30Patients received biphasic insulin aspart 30 before breakfast and before lunch. | Drug | Biphasic Insulin Aspart 30 |
| Insulin Aspart 70Also: Novomix 70Patients received biphasic insulin aspart 70 before breakfast and before lunch. | Drug | Biphasic Insulin Aspart 70 |
Primary outcome
Area Over Basal for Postprandial Glucose From 0 to 600min
Time frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Area Over Basal for Postprandial Triglycerides
Time frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
4 secondary outcomes
Maximum Glucose Increase
Time frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Maximum Triglyceride Increase
Time frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area Over Basal for Postprandial Insulin
Time frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Area Over Basal for Postprandial C-peptide
Time frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Harald Sourij, MD principal investigator
Medical University of Graz, 8036 Graz, Austria
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, Insulin Aspart 30 and Insulin Aspart 70 in people with Type 2 Diabetes, run by Medical University of Graz at 1 site in Austria.
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 7 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 30 Jun 2021. 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 Austria. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Over Basal for Postprandial Glucose From 0 to 600min (time frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)). 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 30 Jun 2021.