DiabetesPhase 3NCT01569841

A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

A Phase 3 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 United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes. Read more about this study

Who is it for?: Ages 18 to 75 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: 24 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Nov 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 1 diabetes
HbA1c (glycosylated haemoglobin) below or equal to 8.5%
Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
BMI (body mass index) below 35 kg/m^2

Who cannot join

Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, 55416-2699

Other trials in United States

About this study

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
Administered subcutaneously (s.c., under the skin) once daily.
insulin glargineDrug
Administered subcutaneously (s.c., under the skin) once daily.

Study groups in NCT01569841
Study group	Role	What they receive
IDeg	Experimental	Not described Receives: Drug: insulin degludec
IGlar	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.

Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.
Measured: CGM occured during the last 2 weeks of the 6 weeks treatment period.

Secondary outcomes (5)

Mean Interstitial Glucose (IG) Based on 14 Days of CGM
The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.
Measured: CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.
Fasting Plasma Glucose (FPG)
FPG after 6 weeks of treatment in each treatment period.
Measured: At the end of each 6 week treatment period.
Glycosylated Haemoglobin (HbA1c)
HbA1c after 6 weeks of treatment in each treatment period.
Measured: At the end of each 6 week treatment period.
Number of Treatment Emergent Adverse Events (AEs)
Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.
Measured: Within each week 6 treatment period
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.
Measured: Hypoglycemic episodes reported within each 6 week treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Nov 2012

First posted3 Apr 2012 (estimated)
Study startApr 2012
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01569841
Sponsor's protocol ID: NN1250-3874
Other IDs: U1111-1125-7495
Status last verified: Jan 2016
First submitted: 30 Mar 2012
Last updated: 18 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT01569841
Acronym / sponsor ID: NN1250-3874
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 3 Apr 2012 (estimated)
Results: Posted 17 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IDeg	Experimental	Drug: insulin degludec
IGlar	Active comparator	Drug: insulin glargine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Type 1 diabetes
HbA1c (glycosylated haemoglobin) below or equal to 8.5%
Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
BMI (body mass index) below 35 kg/m^2

Key exclusion criteria (4 listed)

Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 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 degludecAdministered subcutaneously (s.c., under the skin) once daily.	Drug	IDeg
insulin glargineAdministered subcutaneously (s.c., under the skin) once daily.	Drug	IGlar

Primary outcome

Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
Time frame: CGM occured during the last 2 weeks of the 6 weeks treatment period.
Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.

5 secondary outcomes

Mean Interstitial Glucose (IG) Based on 14 Days of CGM
Time frame: CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.
Fasting Plasma Glucose (FPG)
Time frame: At the end of each 6 week treatment period.
Glycosylated Haemoglobin (HbA1c)
Time frame: At the end of each 6 week treatment period.
Number of Treatment Emergent Adverse Events (AEs)
Time frame: Within each week 6 treatment period
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Time frame: Hypoglycemic episodes reported within each 6 week treatment period.

Results and safety

Results posted to the registry on 17 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDeg/IGlar	12	12
IGlar/IDeg	12	11

Primary outcome: Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)

Time frame: CGM occured during the last 2 weeks of the 6 weeks treatment period.. Mean (Standard Deviation). Unit: hours

Measure	IDeg n = 23	IGlar n = 23
Value	1.39 (0.71)	1.09 (0.77)

Population analysed: The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events were collected during each 6 week treatment period + 7 days follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDeg	0 of 23 (0%)	0 of 23 (0%)	Not reported
IGlar	0 of 24 (0%)	8 of 24 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 3 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 United States.

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 4 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 18 Feb 2016. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) (time frame: CGM occured during the last 2 weeks of the 6 weeks treatment period.). 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 NCT01569841.

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 18 Feb 2016.