DiabetesPhase 3NCT01570751

A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 46 sites in 2 countries.

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 the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, 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: 145 participants
Where: 46 sitesin 2 countries
Study dates: Apr 2012to Jan 2014
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes
Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Who cannot join

Current treatment with insulin other than insulin glargine in vials
Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

Trial locations and contacts

46 sites in 2 countries.

Country

City, postcode or hospital

46 sites in 2 countries

United States45 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Avon, Illinois, 46123
Novo Nordisk Investigational Site
Bradenton, Florida, 34201
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Dallas, Texas, 75218
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Franklin, Ohio, 45005
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Greenbrae, California, 94904
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Homestead, Florida, 33030
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Kingsville, Texas, 78363-6322
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89106
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lexington, Kentucky, 40502
Novo Nordisk Investigational Site
Madisonville, Kentucky, 42431
Novo Nordisk Investigational Site
Mesa, Arizona, 85206
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Miami, Florida, 33155
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Miami Lakes, Florida, 33016
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Nashville, Tennessee, 37212
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
San Antonio, Texas, 78207
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Schertz, Texas, 78154
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Southfield, Michigan, 48034-7661
Novo Nordisk Investigational Site
St. Petersburg, Florida, 33709
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Tacoma, Washington, 98405
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico1 site

Novo Nordisk Investigational Site
Manati, 00674

Other trials in Puerto Rico

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec, insulin glargine
Medical subject headings: Diabetes Mellitus, 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
Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
insulin glargineDrug
Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.

Study groups in NCT01570751
Study group	Role	What they receive
IDeg followed by IGlar	Experimental	Not described Receives: Drug: insulin degludec; Drug: insulin glargine
IGlar followed by IDeg	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.

Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
Values for change in HbA1c after each 16 weeks of treatment periods A and B.
Measured: Week 0, week 16 of each treatment period.

Secondary outcomes (5)

Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period
Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
Measured: Week 0, week 16 of each treatment period.
Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
Measured: Week 16, week 20
Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period
Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.
Measured: Week 0, week 16, week 32
Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.
Measured: Week 16, week 20
Number of Adverse Events (AEs)
Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.
Measured: From baseline to the end of each 16 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 2012Jan 2014

First posted4 Apr 2012 (estimated)
Study startApr 2012
Primary completionJan 2014
Study completionJan 2014

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.
Publications (2)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01570751
Sponsor's protocol ID: NN1250-3943
Other IDs: U1111-1123-4774
Status last verified: Jan 2017
First submitted: 2 Apr 2012
Last updated: 7 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Warren ML, Chaykin LB, Jabbour S, Sheikh-Ali M, Hansen CT, Nielsen TSS, Norwood P. Insulin Degludec 200 Units/mL Is Associated With Lower Injection Frequency and Improved Patient-Reported Outcomes Compared With Insulin Glargine 100 Units/mL in Patients With Type 2 Diabetes Requiring High-Dose Insulin. Clin Diabetes. 2017 Apr;35(2):90-95. doi: 10.2337/cd15-0058.
PubMed 28442823
Warren ML, Brod M, Hakan-Bloch J, Sparre T, Chaykin LB. Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes. Curr Med Res Opin. 2019 Sep;35(9):1623-1629. doi: 10.1080/03007995.2019.1605769. Epub 2019 May 21.
PubMed 30974973

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 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
ClinicalTrials.gov ID: NCT01570751
Acronym / sponsor ID: NN1250-3943
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 4 Apr 2012 (estimated)
Results: Posted 18 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 followed by IGlar	Experimental	Drug: insulin degludec, Drug: insulin glargine
IGlar followed by IDeg	Experimental	Drug: insulin degludec, Drug: insulin glargine

Who may qualify

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

Key inclusion criteria (4 listed)

Type 2 diabetes
Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Key exclusion criteria (4 listed)

Current treatment with insulin other than insulin glargine in vials
Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

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 degludecCross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.	Drug	IDeg followed by IGlar, IGlar followed by IDeg
insulin glargineCross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.	Drug	IDeg followed by IGlar, IGlar followed by IDeg

Primary outcome

Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
Time frame: Week 0, week 16 of each treatment period.
Values for change in HbA1c after each 16 weeks of treatment periods A and B.

5 secondary outcomes

Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period
Time frame: Week 0, week 16 of each treatment period.
Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Time frame: Week 16, week 20
Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period
Time frame: Week 0, week 16, week 32
Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Time frame: Week 16, week 20
Number of Adverse Events (AEs)
Time frame: From baseline to the end of each 16 week treatment period.

Results and safety

Results posted to the registry on 18 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	73	70
IGlar/IDeg	72	67

Primary outcome: Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period

Time frame: Week 0, week 16 of each treatment period.. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	IDeg n = 138	IGlar n = 138
Value	-0.1 (1.1)	-0.1 (1.1)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects in IDeg treatment A and 7 subjects in IGlar treatment B, HbA1c values were missing at the period of baseline and did not contribute to the analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a time frame of 32 weeks + 7 days follow up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDeg	4 of 140 (2.9%)	2 of 140 (1.4%)	Not reported
IGlar	4 of 142 (2.8%)	9 of 142 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28442823Warren ML, Chaykin LB, Jabbour S, Sheikh-Ali M, Hansen CT, Nielsen TSS, Norwood P. Insulin Degludec 200 Units/mL Is Associated With Lower Injection Frequency and Improved Patient-Reported Outcomes Compared With Insulin Glargine 100 Units/mL in Patients With Type 2 Diabetes Requiring High-Dose Insulin. Clin Diabetes. 2017 Apr;35(2):90-95. doi: 10.2337/cd15-0058.
Derived from this study: PubMed 30974973Warren ML, Brod M, Hakan-Bloch J, Sparre T, Chaykin LB. Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes. Curr Med Res Opin. 2019 Sep;35(9):1623-1629. doi: 10.1080/03007995.2019.1605769. Epub 2019 May 21.
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

46 sites in 2 countries: 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 2, run by Novo Nordisk A/S at 46 sites in 2 countries.

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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Puerto Rico. 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 18 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?

Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period (time frame: Week 0, week 16 of each 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 NCT01570751, which also lists 2 linked publications.

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 7 Mar 2017.