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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01664247
First received: August 10, 2012
Last updated: December 15, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: placebo
Drug: liraglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) [ Time Frame: Week 0, week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG after 26 weeks of treatment

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 346
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664247

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
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
United States, Florida
Novo Nordisk Investigational Site
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, 33135
Novo Nordisk Investigational Site
Miami, Florida, United States, 33156
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
United States, Georgia
Novo Nordisk Investigational Site
Decatur, Georgia, United States, 30033
Novo Nordisk Investigational Site
Perry, Georgia, United States, 31069
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Kansas
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Investigational Site
Paducah, Kentucky, United States, 42003
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
United States, Michigan
Novo Nordisk Investigational Site
Buckley, Michigan, United States, 49620
United States, Missouri
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States, 63017-3632
United States, Nevada
Novo Nordisk Investigational Site
Henderson, Nevada, United States, 89052-2649
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
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
United States, North Carolina
Novo Nordisk Investigational Site
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
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45255
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
Novo Nordisk Investigational Site
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
Novo Nordisk Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404-1192
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
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
United States, Texas
Novo Nordisk Investigational Site
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
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
Novo Nordisk Investigational Site
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99218
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Canada, British Columbia
Novo Nordisk Investigational Site
Delta, British Columbia, Canada, V4K 2K5
Canada, Ontario
Novo Nordisk Investigational Site
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
Canada
Novo Nordisk Investigational Site
Quebec, Canada, G3K 2P8
France
Novo Nordisk Investigational Site
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
Germany
Novo Nordisk Investigational Site
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
Israel
Novo Nordisk Investigational Site
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
Italy
Novo Nordisk Investigational Site
Bologna, Italy, 40138
Novo Nordisk Investigational Site
Catanzaro, Italy, 88100
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
Roma, Italy, 00128
Novo Nordisk Investigational Site
Roma, Italy, 00133
Novo Nordisk Investigational Site
Roma, Italy, 00161
Novo Nordisk Investigational Site
Verona, Italy, 37126
Serbia
Novo Nordisk Investigational Site
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
South Africa
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1818
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2198
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4092
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7130
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7708
Ukraine
Novo Nordisk Investigational Site
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
United Arab Emirates
Novo Nordisk Investigational Site
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
United Kingdom
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01664247     History of Changes
Other Study ID Numbers: NN1250-3944
2011-004665-32 ( EudraCT Number )
U1111-1124-6612 ( Other Identifier: WHO )
Study First Received: August 10, 2012
Results First Received: October 23, 2015
Last Updated: December 15, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Liraglutide
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 25, 2017