DiabetesPhase 1NCT01002768
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
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 Austria.
Trial summary
This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 28 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2009to Mar 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Who cannot join
- Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes
This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.
The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
- 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
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
insulin glargineDrug
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
| Study group | Role | What they receive |
|---|---|---|
| IDeg | Experimental | Not described Receives: Drug: insulin degludec |
| IGlar | Experimental | Not described Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
Measured: Within 0-46 hours after last trial product administration
Secondary outcomes (4)
Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose
Measured: Within 0-46 hours after last trial product administration
Time from start of hypoglycaemic induction until each level of plasma glucose is reached
Measured: Within 0-46 hours after last trial product administration
Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L
Measured: Within 0-46 hours after last trial product administration
Hypoglycaemic symptoms score during recovery from hypoglycaemia
Measured: Within 0-46 hours after last trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
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
- 28 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
- NCT01002768
- Sponsor's protocol ID
- NN1250-3538
- Other IDs
- U1111-1111-8843, 2008-008356-16, 2008
- Status last verified
- Jan 2017
- First submitted
- 26 Oct 2009
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia. 2014 Jan;57(1):40-9. doi: 10.1007/s00125-013-3056-0. Epub 2013 Sep 22.
PubMed 24057153
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01002768
- Acronym / sponsor ID
- NN1250-3538
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Oct 2009 (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 iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.
The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDeg | Experimental | Drug: insulin degludec |
| IGlar | Experimental | Drug: insulin glargine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Key exclusion criteria (4 listed)
- Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
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 degludecDay 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement. | Drug | IDeg |
| insulin glargineDay 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement. | Drug | IGlar |
Primary outcome
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
Time frame: Within 0-46 hours after last trial product administration
4 secondary outcomes
Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose
Time frame: Within 0-46 hours after last trial product administration
Time from start of hypoglycaemic induction until each level of plasma glucose is reached
Time frame: Within 0-46 hours after last trial product administration
Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L
Time frame: Within 0-46 hours after last trial product administration
Hypoglycaemic symptoms score during recovery from hypoglycaemia
Time frame: Within 0-46 hours after last trial product administration
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 20 Jan 2017.
- Results publication: PubMed 24057153Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia. 2014 Jan;57(1):40-9. doi: 10.1007/s00125-013-3056-0. Epub 2013 Sep 22.
- 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 Austria.
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 2 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: finished, as of the sponsor's last update on 20 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 Austria. 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?
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration (time frame: Within 0-46 hours after last trial product administration). 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 NCT01002768, 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 20 Jan 2017.