DiabetesPhase 1NCT01865292
Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes
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 is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial… Read more about this study
- Who is it for?
- Ages 18 to 69 years, men only
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- 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
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2006to Nov 2006
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
- Specific inclusion criteria for subject with type 1 diabetes:
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- Specific inclusion criteria for subject with type 2 diabetes:
- Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
- Treated with insulin for the past 3 months prior to screening
- Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)
Who cannot join
- Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
- Subject with a history of or presence of cancer
- Any condition that the Investigator and/or Sponsor feels would interfere with study
- Specific exclusion criteria for subject with type 2 diabetes:
- Therapy with oral antidiabetic drugs within the past 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.
- Being tested
- insulin degludec, insulin glargine
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludecDrug
Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.
insulin glargineDrug
Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec | Experimental | Not described Receives: Drug: insulin degludec |
| Insulin glargine | Active comparator | Not described Receives: 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 after dosing
Secondary outcomes (1)
Area under the insulin degludec/insulin glargine curve
Measured: 0-96 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 posted30 May 2013 (estimated)
- Study startAug 2006
- Primary completionNov 2006
- Study completionNov 2006
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
- 40 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
- NCT01865292
- Sponsor's protocol ID
- NN5401-1719
- Other IDs
- 2006-001915-31
- Status last verified
- Oct 2015
- First submitted
- 27 May 2013
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01865292
- Acronym / sponsor ID
- NN5401-1719
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 30 May 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 is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec | Experimental | Drug: insulin degludec |
| Insulin glargine | Active comparator | Drug: insulin glargine |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
- Specific inclusion criteria for subject with type 1 diabetes:
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- Specific inclusion criteria for subject with type 2 diabetes:
Key exclusion criteria (5 listed)
- Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
- Subject with a history of or presence of cancer
- Any condition that the Investigator and/or Sponsor feels would interfere with study
- Specific exclusion criteria for subject with type 2 diabetes:
- Therapy with oral antidiabetic drugs within the past 3 months prior to 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 degludecThree single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively. | Drug | Insulin degludec |
| insulin glargineThree single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively. | Drug | Insulin glargine |
Primary outcome
Area under the glucose infusion rate curve
Time frame: 0-24 hours after dosing
1 secondary outcome
Area under the insulin degludec/insulin glargine curve
Time frame: 0-96 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 19 Oct 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 8 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 19 Oct 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 after dosing). 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 19 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.