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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

NCT ID: NCT01664247

Last Updated: 2017-09-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IDeg + Lira

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Administered s.c. (under the skin) once daily. Dose individually adjusted.

liraglutide

Intervention Type DRUG

Administered s.c. (under the skin) once daily. Dose: 1.8 mg.

Placebo + Lira

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Administered s.c. (under the skin) once daily. Dose individually adjusted.

liraglutide

Intervention Type DRUG

Administered s.c. (under the skin) once daily. Dose: 1.8 mg.

Interventions

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insulin degludec

Administered s.c. (under the skin) once daily. Dose individually adjusted.

Intervention Type DRUG

placebo

Administered s.c. (under the skin) once daily. Dose individually adjusted.

Intervention Type DRUG

liraglutide

Administered s.c. (under the skin) once daily. Dose: 1.8 mg.

Intervention Type DRUG

Eligibility Criteria

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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)

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Anaheim, California, United States

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Concord, California, United States

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Escondido, California, United States

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Fresno, California, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Monterey, California, United States

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Spring Valley, California, United States

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Walnut Creek, California, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Perry, Georgia, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Topeka, Kansas, United States

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Paducah, Kentucky, United States

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Metairie, Louisiana, United States

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Hyattsville, Maryland, United States

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Buckley, Michigan, United States

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Chesterfield, Missouri, United States

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Henderson, Nevada, United States

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Nashua, New Hampshire, United States

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Lawrenceville, New Jersey, United States

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Toms River, New Jersey, United States

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Northport, New York, United States

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Smithtown, New York, United States

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West Seneca, New York, United States

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Chapel Hill, North Carolina, United States

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Greensboro, North Carolina, United States

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Morehead City, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Franklin, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Humboldt, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Lubbock, Texas, United States

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Round Rock, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Salt Lake City, Utah, United States

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St. George, Utah, United States

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Newport News, Virginia, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Delta, British Columbia, Canada

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Brampton, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, , Canada

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Bron, , France

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Corbeil-Essonnes, , France

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Le Creusot, , France

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Mérignac, , France

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Nanterre, , France

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Niort, , France

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Pau, , France

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Pointe à Pitre, , France

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Saint-denis de La Reunion, , France

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Saint-Herblain, , France

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Vénissieux, , France

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Berlin, , Germany

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Falkensee, , Germany

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Friedrichsthal, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Kirn, , Germany

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Ludwigshafen, , Germany

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Saint Ingbert, , Germany

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Völklingen, , Germany

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Beersheba, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Rishon LeZiyyon, , Israel

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Tel Litwinsky, , Israel

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Bologna, , Italy

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Catanzaro, , Italy

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Milan, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Verona, , Italy

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Belgrade, , Serbia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Novi Sad, , Serbia

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Port Elizabeth, Eastern Cape, South Africa

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Cape Town, Western Cape, South Africa

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Lviv, , Ukraine

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Ternopil, , Ukraine

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Vinnitsa, , Ukraine

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Abu Dhabi, , United Arab Emirates

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Dubai, , United Arab Emirates

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Ras al-Khaimah, , United Arab Emirates

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Sharjah city, , United Arab Emirates

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Birmingham, , United Kingdom

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Bristol, , United Kingdom

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Coventry, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Stevenage, , United Kingdom

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Countries

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United States Canada France Germany Israel Italy Serbia South Africa Ukraine United Arab Emirates United Kingdom

References

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Aroda VR, Bailey TS, Cariou B, Kumar S, Leiter LA, Raskin P, Zacho J, Andersen TH, Philis-Tsimikas A. Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). Diabetes Obes Metab. 2016 Jul;18(7):663-70. doi: 10.1111/dom.12661. Epub 2016 May 2.

Reference Type RESULT
PMID: 26990378 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-004665-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1124-6612

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-3944

Identifier Type: -

Identifier Source: org_study_id