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Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

NCT ID: NCT01388361

Last Updated: 2017-03-06

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

413 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-07-31

Brief Summary

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This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

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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

NONE

Study Groups

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IDeg (non-randomised)

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted

IDeg + IAsp

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted

insulin aspart

Intervention Type DRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

IDeg + liraglutide

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted

liraglutide

Intervention Type DRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Interventions

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insulin degludec

Injected s.c. (under the skin) once daily. The doses will be individually adjusted

Intervention Type DRUG

insulin aspart

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Intervention Type DRUG

liraglutide

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
* The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
* Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Exclusion Criteria

* Participated in NN1250-3643 and treated with insulin glargine
* Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
* Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
* Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin \[For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula\] at end of treatment in NN1250-3643.
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

Concord, California, United States

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La Jolla, California, United States

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Lancaster, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Northridge, California, United States

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Palm Springs, California, United States

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Santa Monica, California, United States

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Spring Valley, California, United States

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Tarzana, California, United States

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Tustin, California, United States

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Boynton Beach, Florida, United States

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Melbourne, 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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West Palm Beach, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Paducah, Kentucky, United States

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Metairie, Louisiana, United States

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Slidell, Louisiana, United States

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North East, Maryland, United States

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Rockville, Maryland, 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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Staten Island, New York, United States

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Asheboro, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Melrose Park, Pennsylvania, United States

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Upper Saint Clair, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Chattanooga, Tennessee, United States

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Humboldt, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Irving, Texas, United States

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Lubbock, 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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Milwaukee, Wisconsin, United States

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Feldkirch, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Wolfsberg, , Austria

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Edmonton, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Saint-Marc-des-Carrieres, Quebec, Canada

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Brno, , Czechia

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Hradec Králové, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Esbjerg, , Denmark

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Hillerød, , Denmark

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Holbæk, , Denmark

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København S, , Denmark

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Odense, , Denmark

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Silkeborg, , Denmark

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Helsinki, , Finland

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Joensuu, , Finland

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Kerava, , Finland

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Lohja, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Montigny-lès-Metz, , France

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Nanterre, , France

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Nîmes, , France

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Vénissieux, , France

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Berlin, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Essen, , Germany

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Friedrichsthal, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Neuwied, , Germany

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Pohlheim, , Germany

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Rehburg-Loccum, , Germany

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Rehlingen-Siersburg, , Germany

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Saint Ingbert, , Germany

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Speyer, , Germany

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Ålesund, , Norway

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Bekkestua, , Norway

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Elverum, , Norway

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Hamar, , Norway

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Kongsvinger, , Norway

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Oslo, , Norway

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Stavanger, , Norway

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Trondheim, , Norway

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Almería, , Spain

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Antequera, , Spain

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Ferrol, , Spain

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Inca, , Spain

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Palma de Mallorca, , Spain

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Seville, , Spain

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Seville, , Spain

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Countries

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United States Austria Belgium Canada Czechia Denmark Finland France Germany Norway Serbia Spain

References

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Mathieu C, Rodbard HW, Cariou B, Handelsman Y, Philis-Tsimikas A, Ocampo Francisco AM, Rana A, Zinman B; BEGIN: VICTOZA ADD-ON (NN1250-3948) study group. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014 Jul;16(7):636-44. doi: 10.1111/dom.12262. Epub 2014 Feb 11.

Reference Type RESULT
PMID: 24443830 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-001493-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1120-2782

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-3948

Identifier Type: -

Identifier Source: org_study_id

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