Diabetes MellitusPhase 4APPLYNCT00607737
Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes
A Phase 4 study testing insulin detemir and saline in people with Diabetes Mellitus, run by Lise Tarnow at 1 site in Denmark.
Trial summary
To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes The patient serves as his own control, n=100 patients with diabetes Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- insulin detemir and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Jul 2010
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diabetes mellitus
- HbA1c<11 %
- BMI: 20-35 kg/m2
- Insulin detemir naive
- Basal insulin dose>20E
Who cannot join
- Known allergy to study drug
- Current steroid or antiallergic treatment
- Lipodystrophy
- Change in insulin and antihypertensive treatment < 30 days
- Smokers or alcoholics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus
To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes
- The patient serves as his own control, n=100 patients with diabetes
- Conditions
- Diabetes Mellitus
- Being tested
- insulin detemir, saline
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
3 cutaneous injections
salineDrug
3 cutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | insulin detemir Receives: Drug: insulin detemir |
| 2 | Placebo comparator | saline Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
laser doppler blood flow
Measured: 10 minutes - 7 days
Secondary outcomes (2)
clinical signs
Measured: 10 min - 7 days
insulin detemir specific antibodies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lise Tarnow
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Lise Tarnow, Steno Diabetes Center Copenhagen
- Investigators
- LIse Tarnow, md, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607737
- Sponsor's protocol ID
- APPLY
- Other IDs
- EudraCT 2007-005677-59
- Acronym
- APPLY
- Status last verified
- Aug 2012
- First submitted
- 23 Jan 2008
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00607737
- Acronym / sponsor ID
- APPLY / APPLY
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lise TarnowUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Feb 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.
To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes
- The patient serves as his own control, n=100 patients with diabetes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: insulin detemirinsulin detemir |
| 2 | Placebo comparator | Drug: salinesaline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diabetes mellitus
- HbA1c<11 %
- BMI: 20-35 kg/m2
- Insulin detemir naive
- Basal insulin dose>20E
Key exclusion criteria (5 listed)
- Known allergy to study drug
- Current steroid or antiallergic treatment
- Lipodystrophy
- Change in insulin and antihypertensive treatment < 30 days
- Smokers or alcoholics
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 detemir3 cutaneous injections | Drug | 1 |
| saline3 cutaneous injections | Drug | 2 |
Primary outcome
laser doppler blood flow
Time frame: 10 minutes - 7 days
2 secondary outcomes
clinical signs
Time frame: 10 min - 7 days
insulin detemir specific antibodies
Time frame: 3 months
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 3 Sep 2012.
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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.
LIse Tarnow, md principal investigator
Steno Diabetes Center Copenhagen
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 detemir and saline in people with Diabetes Mellitus, run by Lise Tarnow 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 5 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 3 Sep 2012. 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. Some participants in this study may receive a placebo. 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?
laser doppler blood flow (time frame: 10 minutes - 7 days). 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 3 Sep 2012.