DiabetesPhase 1NCT01497574
Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
A Phase 1 study testing insulin detemir and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 1, 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 compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin detemir and insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Oct 2005
- Phase
- Phase 1
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes for at least 12 months
- Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m^2 (both inclusive)
- Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m^2 (both inclusive)
- HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results
- Current treatment with insulin at least twice daily
Who cannot join
- Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes
- Receipt of any investigational product within the last four weeks
- Known or suspected allergy to trial products or related products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Cross-over Trial Comparing the Within-subject Variability of the Pharmacokinetic Profiles of Insulin Detemir and Insulin Glargine in Children and Adolescents With Type 1 Diabetes
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin detemir, insulin glargine
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
On two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
insulin glargineDrug
On two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir | Experimental | Not described Receives: Drug: insulin detemir; Drug: insulin glargine |
| Insulin glargine | Active comparator | Not described Receives: Drug: insulin detemir; Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the insulin concentration curve (AUC)
Secondary outcomes (3)
Maximum insulin concentration (Cmax)
Time to maximum insulin concentration (tmax)
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startMay 2005
- Primary completionOct 2005
- Study completionOct 2005
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT01497574
- Sponsor's protocol ID
- NN304-1633
- Other IDs
- 2004-001692-19, 2004
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2011
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Danne T, Datz N, Endahl L, Haahr H, Nestoris C, Westergaard L, Fjording MS, Kordonouri O. Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial. Pediatr Diabetes. 2008 Dec;9(6):554-60. doi: 10.1111/j.1399-5448.2008.00443.x. Epub 2008 Aug 27.
PubMed 18761644
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Cross-over Trial Comparing the Within-subject Variability of the Pharmacokinetic Profiles of Insulin Detemir and Insulin Glargine in Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01497574
- Acronym / sponsor ID
- NN304-1633
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 22 Dec 2011 (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 compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir | Experimental | Drug: insulin detemir, Drug: insulin glargine |
| Insulin glargine | Active comparator | Drug: insulin detemir, Drug: insulin glargine |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Type 1 diabetes for at least 12 months
- Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m^2 (both inclusive)
- Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m^2 (both inclusive)
- HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results
- Current treatment with insulin at least twice daily
Key exclusion criteria (3 listed)
- Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes
- Receipt of any investigational product within the last four weeks
- Known or suspected allergy to trial products or related products
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 detemirOn two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin) | Drug | Insulin detemir, Insulin glargine |
| insulin glargineOn two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin) | Drug | Insulin detemir, Insulin glargine |
Primary outcome
Area under the insulin concentration curve (AUC)
3 secondary outcomes
Maximum insulin concentration (Cmax)
Time to maximum insulin concentration (tmax)
Adverse events
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 30 Jan 2017.
- Results publication: PubMed 18761644Danne T, Datz N, Endahl L, Haahr H, Nestoris C, Westergaard L, Fjording MS, Kordonouri O. Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial. Pediatr Diabetes. 2008 Dec;9(6):554-60. doi: 10.1111/j.1399-5448.2008.00443.x. Epub 2008 Aug 27.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 1 study testing insulin detemir and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 1, 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 5 inclusion and 3 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 Jan 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the insulin concentration curve (AUC). 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 NCT01497574, 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 30 Jan 2017.