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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

October 1, 2012

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

December 31, 2013

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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