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: March 12, 2014
Last verified: March 2014
  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 in subjects with type 2 diabetes qualifying for treatment intensification.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of responders for HbA1c (below 7.0 %) [ Time Frame: After 26 weeks of randomised treatment ] [ Designated as safety issue: No ]
  • Change from baseline in mean pre-breakfast measurements used for titration [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in 8-point profile [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in mean of the 8-point profile [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 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.
Placebo Comparator: Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520
Novo Nordisk Clinical Trial Call Center
Escondido, California, United States, 92026
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
Novo Nordisk Clinical Trial Call Center
Huntington Beach, California, United States, 92648
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Monterey, California, United States, 93940
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Florida
Novo Nordisk Clinical Trial Call Center
Boynton Beach, Florida, United States, 33472
Novo Nordisk Clinical Trial Call Center
Clearwater, Florida, United States, 33765
Novo Nordisk Clinical Trial Call Center
Hollywood, Florida, United States, 33021
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32207
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33135-1687
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33156
Novo Nordisk Clinical Trial Call Center
New Port Richey, Florida, United States, 34652
Novo Nordisk Clinical Trial Call Center
Palm Harbor, Florida, United States, 34684
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Decatur, Georgia, United States, 30033
Novo Nordisk Clinical Trial Call Center
Perry, Georgia, United States, 31069
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
Novo Nordisk Clinical Trial Call Center
Springfield, Illinois, United States, 62704
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Paducah, Kentucky, United States, 42003
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Buckley, Michigan, United States, 49620
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Chesterfield, Missouri, United States, 63017
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Henderson, Nevada, United States, 89052-2649
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Clinical Trial Call Center
(151A) Northport, New York, United States, 11768
Novo Nordisk Clinical Trial Call Center
Smithtown, New York, United States, 11787
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27713
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
Novo Nordisk Clinical Trial Call Center
Morehead City, North Carolina, United States, 28557
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45255
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
Novo Nordisk Clinical Trial Call Center
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
Novo Nordisk Clinical Trial Call Center
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Clinical Trial Call Center
Humboldt, Tennessee, United States, 38343
Novo Nordisk Clinical Trial Call Center
Johnson City, Tennessee, United States, 37604
Novo Nordisk Clinical Trial Call Center
Nashville, Tennessee, United States, 37212
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75390-8858
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75231
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Irving, Texas, United States, 75061-2210
Novo Nordisk Clinical Trial Call Center
Lubbock, Texas, United States, 79423
Novo Nordisk Clinical Trial Call Center
Round Rock, Texas, United States, 78681
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78224
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
Novo Nordisk Clinical Trial Call Center
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
United States, Washington
Novo Nordisk Clinical Trial Call Center
Spokane, Washington, United States, 99218
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, United States, 53209
Canada, Ontario
Toronto, Ontario, Canada, M9V 4B4
France
Bordeaux, France, 33200
Germany
Hamburg, Germany, 22607
Israel
Jerusalem, Israel, 91240
Italy
Milano, Italy, 20132
Serbia
Belgrade, Serbia, 11000
South Africa
Port Elizabeth, Eastern Cape, South Africa, 6014
Johannesburg, Gauteng, South Africa, 1818
Ukraine
Lviv, Ukraine, 79010
United Arab Emirates
Dubai, United Arab Emirates, 4545
Ras Al Khaimah, United Arab Emirates, 4727
Sharjah, United Arab Emirates, 3500
United Kingdom
London, United Kingdom, W6 7HY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Kathleen Stolpe Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01664247     History of Changes
Other Study ID Numbers: NN1250-3944, 2011-004665-32, U1111-1124-6612
Study First Received: August 10, 2012
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: Ministry of Health
Serbia: Medicines and Medical Devices Agency of Serbia
South Africa: Medicines Control Council
Ukraine: Ministry of Health Ukraine
United Arab Emirates: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014