Type 2 Diabetes MellitusPhase 2NCT01510093
Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
A Phase 2 study testing Insulin Aspart 100 IE/ml in people with Type 2 Diabetes Mellitus, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Aspart 100 IE/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Jan 2013
- Phase
- Phase 2
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes mellitus
- Insulin-naive patients
- HbA1C < 9%
- Women and men >= 35 and <= 75 years old
- BMI 25-42 kg/m2, both values are included
Who cannot join
- Suspected or known allergy to the trial drug or similar medications
- Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels
- Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months
- Severe uncontrolled hypertension with blood pressure in lying position > 180/110 mmHg
- Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory
- Impaired kidney function with eGFR < 50 ml/min according to the local laboratory
- Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology and Internal Diseases
Aarhus C, Central Jutland, 8000
About this study
Official title: Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients
This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised.
Hypotheses:
- Secretion of endogenous insulin depends on exogenous insulin supply
- Secretion of endogenous insulin is depends on plasma glucose levels
Read the detailed description
There are a screening visit and two treatment sessions:
Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Aspart 100 IE/ml
- Keywords
- type 2 diabetes mellitus, endogenous insulin
- 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 Aspart 100 IE/mlDrug
Also called NovoRapid 100 IE/ml
1.5 IE/hour/subject/visit. Each vist takes 10 hours
| Study group | Role | What they receive |
|---|---|---|
| Insulin Aspart without glucose supply | Other | Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply Receives: Drug: Insulin Aspart 100 IE/ml |
| Insulin Aspart with glucose supply | Other | Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply Receives: Drug: Insulin Aspart 100 IE/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose
Measured: 10 hours
Secondary outcomes (1)
Pharmacodynamic glucose profiles
Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionJan 2013
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgita Janukonyte, Aarhus University Hospital
- Investigators
- Jurgita Janukonyte, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510093
- Sponsor's protocol ID
- 2011/1811
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janukonyte J, Parkner T, Bruun NH, Lauritzen T, Christiansen JS, Laursen T. Interaction between exogenous insulin, endogenous insulin, and glucose in type 2 diabetes patients. Diabetes Technol Ther. 2015 May;17(5):335-42. doi: 10.1089/dia.2014.0326. Epub 2015 Mar 18.
PubMed 25785658
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT01510093
- Acronym / sponsor ID
- 2011/1811
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, endogenous insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Jan 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 is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised.
Hypotheses:
- Secretion of endogenous insulin depends on exogenous insulin supply
- Secretion of endogenous insulin is depends on plasma glucose levels
Detailed description
There are a screening visit and two treatment sessions:
Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Aspart without glucose supply | Other | Drug: Insulin Aspart 100 IE/mlTreatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply |
| Insulin Aspart with glucose supply | Other | Drug: Insulin Aspart 100 IE/mlTreatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with type 2 diabetes mellitus
- Insulin-naive patients
- HbA1C < 9%
- Women and men >= 35 and <= 75 years old
- BMI 25-42 kg/m2, both values are included
Key exclusion criteria (7 listed)
- Suspected or known allergy to the trial drug or similar medications
- Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels
- Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months
- Severe uncontrolled hypertension with blood pressure in lying position > 180/110 mmHg
- Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory
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 Aspart 100 IE/mlAlso: NovoRapid 100 IE/ml1.5 IE/hour/subject/visit. Each vist takes 10 hours | Drug | Insulin Aspart with glucose supply, Insulin Aspart without glucose supply |
Primary outcome
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
Time frame: 10 hours
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose
1 secondary outcome
Pharmacodynamic glucose profiles
Time frame: 10 hours
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 29 Jan 2013.
- Derived from this study: PubMed 25785658Janukonyte J, Parkner T, Bruun NH, Lauritzen T, Christiansen JS, Laursen T. Interaction between exogenous insulin, endogenous insulin, and glucose in type 2 diabetes patients. Diabetes Technol Ther. 2015 May;17(5):335-42. doi: 10.1089/dia.2014.0326. Epub 2015 Mar 18.
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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.
Jurgita Janukonyte, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin Aspart 100 IE/ml in people with Type 2 Diabetes Mellitus, run by Aarhus University Hospital at 1 site in Denmark.
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 7 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 29 Jan 2013. 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart (time frame: 10 hours). 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 NCT01510093, 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 29 Jan 2013.