Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin (BEGIN™)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01388361
First received: July 4, 2011
Last updated: July 10, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin degludec Drug: insulin aspart Drug: liraglutide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON) |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Insulin human
Insulin aspart
Liraglutide
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change from baseline in HbA1c (%) (glycosylated haemoglobin) [ 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 ]
- Change from baseline in body weight [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
- Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: that have onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product ] [ Designated as safety issue: No ]
| Enrollment: | 413 |
| Study Start Date: | September 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IDeg + IAsp |
Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Drug: insulin aspart
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
|
| Experimental: IDeg + liraglutide |
Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Drug: liraglutide
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
|
| Experimental: IDeg (non-randomised) |
Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388361
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| United States, Arizona | |
| Novo Nordisk Clinical Trial Call Center | |
| Goodyear, Arizona, United States, 85395 | |
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Concord, California, United States, 94520-1926 | |
| Novo Nordisk Clinical Trial Call Center | |
| La Jolla, California, United States, 92037 | |
| Novo Nordisk Clinical Trial Call Center | |
| Lancaster, California, United States, 93534 | |
| Novo Nordisk Clinical Trial Call Center | |
| Los Angeles, California, United States, 90057 | |
| Novo Nordisk Clinical Trial Call Center | |
| National City, California, United States, 91950 | |
| Novo Nordisk Clinical Trial Call Center | |
| Northridge, California, United States, 91325 | |
| Novo Nordisk Clinical Trial Call Center | |
| Palm Springs, California, United States, 92262 | |
| Novo Nordisk Clinical Trial Call Center | |
| Spring Valley, California, United States, 91978 | |
| Novo Nordisk Clinical Trial Call Center | |
| Tarzana, California, United States, 91356-3551 | |
| Novo Nordisk Clinical Trial Call Center | |
| Tustin, California, United States, 92780 | |
| United States, Florida | |
| Novo Nordisk Clinical Trial Call Center | |
| Boynton Beach, Florida, United States, 33472 | |
| Novo Nordisk Clinical Trial Call Center | |
| Melbourne, Florida, United States, 32901 | |
| 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 | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Georgia | |
| Novo Nordisk Clinical Trial Call Center | |
| Atlanta, Georgia, United States, 30322 | |
| Novo Nordisk Clinical Trial Call Center | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Novo Nordisk Clinical Trial Call Center | |
| Chicago, Illinois, United States, 60607 | |
| 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 | |
| Novo Nordisk Clinical Trial Call Center | |
| Slidell, Louisiana, United States, 70461-4231 | |
| United States, Maryland | |
| Novo Nordisk Clinical Trial Call Center | |
| North East, Maryland, United States, 21901 | |
| Novo Nordisk Clinical Trial Call Center | |
| Rockville, Maryland, United States, 20852 | |
| United States, New Jersey | |
| Novo Nordisk Clinical Trial Call Center | |
| Toms River, New Jersey, United States, 08755-8050 | |
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| Northport, New York, United States, 11768 | |
| Novo Nordisk Clinical Trial Call Center | |
| Staten Island, New York, United States, 10301 | |
| United States, North Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Asheboro, North Carolina, United States, 27203 | |
| United States, Ohio | |
| Novo Nordisk Clinical Trial Call Center | |
| Cincinnati, Ohio, United States, 45245 | |
| United States, Oklahoma | |
| Novo Nordisk Clinical Trial Call Center | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Pennsylvania | |
| Novo Nordisk Clinical Trial Call Center | |
| Melrose Park, Pennsylvania, United States, 19027 | |
| Novo Nordisk Clinical Trial Call Center | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| Novo Nordisk Clinical Trial Call Center | |
| Upper St. Clair, Pennsylvania, United States, 15241 | |
| United States, Rhode Island | |
| Novo Nordisk Clinical Trial Call Center | |
| East Providence, Rhode Island, United States, 02914 | |
| United States, South Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Columbia, South Carolina, United States, 29203 | |
| Novo Nordisk Clinical Trial Call Center | |
| Greer, South Carolina, United States, 29651 | |
| United States, Tennessee | |
| Novo Nordisk Clinical Trial Call Center | |
| Brentwood, Tennessee, United States, 37027 | |
| Novo Nordisk Clinical Trial Call Center | |
| Chattanooga, Tennessee, United States, 37411 | |
| Novo Nordisk Clinical Trial Call Center | |
| Humboldt, Tennessee, United States, 38343-3634 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| Arlington, Texas, United States, 76014 | |
| 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 | |
| Fort Worth, Texas, United States, 76113 | |
| 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 | |
| San Antonio, Texas, United States, 78215 | |
| Novo Nordisk Clinical Trial Call Center | |
| Sugar Land, Texas, United States, 77479 | |
| United States, Wisconsin | |
| Novo Nordisk Clinical Trial Call Center | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Austria | |
| Wien, Austria, 1130 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T5J 3N4 | |
| Czech Republic | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Denmark | |
| København S, Denmark, 2300 | |
| Finland | |
| Tampere, Finland, 33210 | |
| France | |
| Montigny-les-Metz, France, 57950 | |
| Germany | |
| Neuwied, Germany, 56564 | |
| Norway | |
| Stavanger, Norway, 4011 | |
| Serbia | |
| Belgrade, Serbia, 11000 | |
| Spain | |
| Sevilla, Spain, 41003 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Cathrine Buur Johansen | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01388361 History of Changes |
| Other Study ID Numbers: | NN1250-3948, 2011-001493-25, U1111-1120-2782 |
| Study First Received: | July 4, 2011 |
| Last Updated: | July 10, 2012 |
| Health Authority: | Austria: AGES PharmMed Belgium: Federal Agency for Medicines and Health Products Canada: Health Canada Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Fimea France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medicinal Devices (BfarM) Norway: Norwegian Medicines Agency Serbia: Medicines and Medical Devices Agency of Serbia Spain: Spanish Drug Agency and Medicinal Products 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 aspart |
Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013