DiabetesPhase 1NCT01868529
Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
A Phase 1 study testing insulin degludec 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 was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin degludec and insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Jun 2008
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months
- Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2 (both inclusive)
- Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
- Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day
Who cannot join
- Known or suspected allergy to trial product(s) or related products
- Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
- Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus
This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin degludec, 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 degludecDrug
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
insulin glargineDrug
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: insulin degludec; Drug: insulin glargine |
| Medium dose | Experimental | Not described Receives: Drug: insulin degludec; Drug: insulin glargine |
| High dose | Experimental | Not described Receives: Drug: insulin degludec; Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the glucose infusion rate curve
Measured: 0-24 hours in steady-state
Secondary outcomes (1)
Area under the serum insulin concentration curve at steady state
Measured: 0-24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 63 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
- NCT01868529
- Sponsor's protocol ID
- NN1250-1876
- Other IDs
- 2007-003534-41
- Status last verified
- Sep 2015
- First submitted
- 30 May 2013
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01868529
- Acronym / sponsor ID
- NN1250-1876
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Jun 2013 (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 was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: insulin degludec, Drug: insulin glargine |
| Medium dose | Experimental | Drug: insulin degludec, Drug: insulin glargine |
| High dose | Experimental | Drug: insulin degludec, Drug: insulin glargine |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months
- Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2 (both inclusive)
- Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
- Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day
Key exclusion criteria (3 listed)
- Known or suspected allergy to trial product(s) or related products
- Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
- Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
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 degludecOnce daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment. | Drug | High dose, Low dose, Medium dose |
| insulin glargineOnce daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment. | Drug | High dose, Low dose, Medium dose |
Primary outcome
Area under the glucose infusion rate curve
Time frame: 0-24 hours in steady-state
1 secondary outcome
Area under the serum insulin concentration curve at steady state
Time frame: 0-24 hours after dosing
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 28 Sep 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
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 degludec 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 28 Sep 2015. 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 glucose infusion rate curve (time frame: 0-24 hours in steady-state). 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 28 Sep 2015.