The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

August 25, 2017 updated by: Novo Nordisk A/S
This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
346

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G3K 2P8
        • Novo Nordisk Investigational Site
    • British Columbia
      • Delta, British Columbia, Canada, V4K 2K5
        • Novo Nordisk Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6P 1A9
        • Novo Nordisk Investigational Site
      • Ottawa, Ontario, Canada, K1N 1A2
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Novo Nordisk Investigational Site
  • France
      • Bron, France, 69677
        • Novo Nordisk Investigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk Investigational Site
      • Merignac, France, 33700
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Niort, France, 79021
        • Novo Nordisk Investigational Site
      • Pau, France, 64000
        • Novo Nordisk Investigational Site
      • Pointe à Pitre, France, 97159
        • Novo Nordisk Investigational Site
      • Saint Herblain, France, 44800
        • Novo Nordisk Investigational Site
      • Saint-denis de La Reunion, France, 97405
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 12163
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Kirn, Germany, 55606
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Rishon Le Zion, Israel, 75650
        • Novo Nordisk Investigational Site
      • Tel Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Novo Nordisk Investigational Site
      • Catanzaro, Italy, 88100
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00161
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00133
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00128
        • Novo Nordisk Investigational Site
      • Verona, Italy, 37126
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Belgrade, Serbia, 11080
        • Novo Nordisk Investigational Site
      • Kragujevac, Serbia, 34000
        • Novo Nordisk Investigational Site
      • Novi Sad, Serbia, 21000
        • Novo Nordisk Investigational Site
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6014
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1818
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 2198
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7700
        • Novo Nordisk Investigational Site
  • Ukraine
      • Kharkiv, Ukraine, 61000
        • Novo Nordisk Investigational Site
      • Kiev, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Lviv, Ukraine, 79010
        • Novo Nordisk Investigational Site
      • Ternopil, Ukraine, 46002
        • Novo Nordisk Investigational Site
      • Vinnitsa, Ukraine, 21010
        • Novo Nordisk Investigational Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 51900
        • Novo Nordisk Investigational Site
      • Dubai, United Arab Emirates, 4545
        • Novo Nordisk Investigational Site
      • Ras Al Khaimah, United Arab Emirates, 4727
        • Novo Nordisk Investigational Site
      • Sharjah, United Arab Emirates, 3500
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV2 2DX
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE1 9RT
        • Novo Nordisk Investigational Site
      • London, United Kingdom, W6 7HY
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Huntington Beach, California, United States, 92648
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Monterey, California, United States, 93940
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33765
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33135
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Novo Nordisk Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Novo Nordisk Investigational Site
      • Perry, Georgia, United States, 31069
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017-3632
        • Novo Nordisk Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052-2649
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
      • Toms River, New Jersey, United States, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
      • Smithtown, New York, United States, 11787
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Novo Nordisk Investigational Site
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19152
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37404-1192
        • Novo Nordisk Investigational Site
      • Humboldt, Tennessee, United States, 38343
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Novo Nordisk Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030-2703
        • Novo Nordisk Investigational Site
      • Irving, Texas, United States, 75061-2210
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk Investigational Site
      • Round Rock, Texas, United States, 78681
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78224
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
    • Utah
      • Saint George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99218
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Insulin naïve
  • Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))
  • Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)

Exclusion Criteria:

  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
  • Calcitonin equal to or above 50 pg/mL
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
  • Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IDeg + Lira
Drug: insulin degludec
Administered s.c. (under the skin) once daily. Dose individually adjusted.
Drug: liraglutide
Administered s.c. (under the skin) once daily. Dose: 1.8 mg.
Experimental: Placebo + Lira
Drug: liraglutide
Administered s.c. (under the skin) once daily. Dose: 1.8 mg.
Drug: placebo
Administered s.c. (under the skin) once daily. Dose individually adjusted.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Time Frame: Week 0, week 26
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
Change from baseline in FPG after 26 weeks of treatment
Week 0, week 26
Number of Responders for HbA1c (Below 7.0 %)
Time Frame: After 26 weeks of randomised treatment.
Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.
After 26 weeks of randomised treatment.
Change From Baseline in Mean Pre-breakfast Measurements Used for Titration
Time Frame: Week 0, week 26
Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
Week 0, week 26
Change From Baseline in 8-point Profile
Time Frame: Week 0, week 26
The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
Week 0, week 26
Change From Baseline in Mean of the 8-point Profile
Time Frame: Week 0, week 26
Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.
Week 0, week 26
Number of Hypoglycaemic Episodes
Time Frame: Weeks 0 - 26
Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.
Weeks 0 - 26
Number of Adverse Events
Time Frame: Weeks 0 - 26
Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. 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.
Weeks 0 - 26
Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)
Time Frame: Week 0, week 26
Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.
Week 0, week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN1250-3944
  • 2011-004665-32 (EudraCT Number)
  • U1111-1124-6612 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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