Diabetes MellitusPhase 4NCT00490893
Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir
A Phase 4 study testing Detemir in people with Diabetes Mellitus and Hypoglycemia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypoglycemia
- What is being tested?
- Detemir
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Dec 2006
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects male or female
- Age 18-50 years
- Female subjects save contraception
- Ability to take part in the study
- Signed consent
Who cannot join
- Chronic disease
- Acute disease during 4 weeks prior to the study
- Pregnancy
- Drug treatment other than hormonal contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia
Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.
- Conditions
- Diabetes Mellitus, Hypoglycemia
- Being tested
- Detemir
- Keywords
- counterregulation, hypoglycemia unawareness, insulin therapy
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DetemirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormone response to hypoglycemia (Glucagon)
Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia
Secondary outcomes (2)
Hormone response to glucagon (epinephrine, growth hormne, cortisol)
Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startMar 2006
- Study completionDec 2006
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.
- More trials run by University Hospital TuebingenThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Fritsche, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490893
- Sponsor's protocol ID
- 2005-003940-79
- Other IDs
- 2005
- Status last verified
- Jun 2007
- First submitted
- 22 Jun 2007
- Last updated
- 25 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia
- ClinicalTrials.gov ID
- NCT00490893
- Acronym / sponsor ID
- 2005-003940-79
- Conditions
- Diabetes Mellitus, Hypoglycemia
- Keywords
- counterregulation, hypoglycemia unawareness, insulin therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Jun 2007 (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.
Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects male or female
- Age 18-50 years
- Female subjects save contraception
- Ability to take part in the study
- Signed consent
Key exclusion criteria (4 listed)
- Chronic disease
- Acute disease during 4 weeks prior to the study
- Pregnancy
- Drug treatment other than hormonal contraception
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 |
|---|---|---|
| Detemir | Drug | – |
Primary outcome
Hormone response to hypoglycemia (Glucagon)
Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia
2 secondary outcomes
Hormone response to glucagon (epinephrine, growth hormne, cortisol)
Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2007.
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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.
Andreas Fritsche, MD principal investigator
University Hospital Tuebingen
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 Detemir in people with Diabetes Mellitus and Hypoglycemia, run by University Hospital Tuebingen 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 4 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: stopped early, as of the sponsor's last update on 25 Jun 2007. 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 was stopped early. Results are not available in the source record.
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?
Hormone response to hypoglycemia (Glucagon). 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 25 Jun 2007.