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Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00982644
First received: September 22, 2009
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

This trial is conducted in Europe and the United States of America (USA).

The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

Main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: insulin glargine
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: NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 104 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 104 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 104 + 7 days of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment [ Time Frame: Week 0, Week 104 ] [ Designated as safety issue: No ]
  • Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
  • Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]

Enrollment: 1029
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg OD Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Active Comparator: IGlar OD Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was 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 mellitus
  • Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
  • HbA1c: 7.0-10.0%
  • Body Mass Index (BMI) no higher than 40.0 kg/m^2
  • For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)

Exclusion Criteria:

  • Treatment with exenatide or liraglutide within the last 3 months before trial start
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
  • Cancer and medical history of cancer
  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: NCT00982644

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Bay Minette, Alabama, United States, 36507-4198
Novo Nordisk Clinical Trial Call Center
Huntsville, Alabama, United States, 35801
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Goodyear, Arizona, United States, 85395
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520-1926
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
Long Beach, California, United States, 90806
Novo Nordisk Clinical Trial Call Center
Mission Hills, California, United States, 91345
Novo Nordisk Clinical Trial Call Center
National City, California, United States, 91950
Novo Nordisk Clinical Trial Call Center
North Hollywood, California, United States, 91606
Novo Nordisk Clinical Trial Call Center
Northridge, California, United States, 91325
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States, 92262-6972
Novo Nordisk Clinical Trial Call Center
San Mateo, California, United States, 94401
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, Connecticut
Novo Nordisk Clinical Trial Call Center
Norwalk, Connecticut, United States, 06851-4697
United States, Florida
Novo Nordisk Clinical Trial Call Center
Boynton Beach, Florida, United States, 33472
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32208
Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32901
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33169
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
Orange Park, Florida, United States, 32073
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
Decatur, Georgia, United States, 30033
Novo Nordisk Clinical Trial Call Center
Fort Valley, Georgia, United States, 31030-5008
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47714
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
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
Greenbelt, Maryland, United States, 20770
Novo Nordisk Clinical Trial Call Center
North East, Maryland, United States, 21901
Novo Nordisk Clinical Trial Call Center
Reisterstown, Maryland, United States, 21136-2516
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Brockton, Massachusetts, United States, 02301
Novo Nordisk Clinical Trial Call Center
North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63104
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Henderson, Nevada, United States, 89052-2649
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89117
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
Novo Nordisk Clinical Trial Call Center
Charlotte, North Carolina, United States, 28209
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45255
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45406
Novo Nordisk Clinical Trial Call Center
Toledo, Ohio, United States, 43606-2920
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Kingston, Pennsylvania, United States, 18704
Novo Nordisk Clinical Trial Call Center
Langhorne, Pennsylvania, United States, 19047
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
West Reading, Pennsylvania, United States, 19611
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
Novo Nordisk Clinical Trial Call Center
Newberry, South Carolina, United States, 29108-2249
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Harriman, Tennessee, United States, 37748-8653
Novo Nordisk Clinical Trial Call Center
Humboldt, Tennessee, United States, 38343
Novo Nordisk Clinical Trial Call Center
Nashville, Tennessee, United States, 37203
United States, Texas
Novo Nordisk Clinical Trial Call Center
Arlington, Texas, United States, 76014
Novo Nordisk Clinical Trial Call Center
Corpus Christi, Texas, United States, 78404
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
El Paso, Texas, United States, 79925
Novo Nordisk Clinical Trial Call Center
Hurst, Texas, United States, 76054
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, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23233
United States, Washington
Novo Nordisk Clinical Trial Call Center
Spokane, Washington, United States, 99218
Austria
Wolfsberg, Austria, A 9400
Belgium
Liège, Belgium, 4000
Canada, Alberta
Edmonton, Alberta, Canada, T5J 3N4
Czech Republic
Hradec Kralove, Czech Republic, 500 05
Denmark
Silkeborg, Denmark, 8600
Finland
Tampere, Finland, 33210
France
Saint-denis de La Reunion, France, 97405
Germany
Rehburg-Loccum, Germany, 31547
Norway
Hamar, Norway, 2318
Puerto Rico
Novo Nordisk Clinical Trial Call Center
Bayamon, Puerto Rico, 00961
Serbia
Kragujevac, Serbia, 34000
Spain
Inca, Spain, 07300
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00982644     History of Changes
Obsolete Identifiers: NCT01193309
Other Study ID Numbers: NN1250-3579, 2008-005776-27, U1111-1111-8692, 2009-015754-38, U1111-1114-9426
Study First Received: September 22, 2009
Last Updated: May 28, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Healthcare Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Norway: Norwegian Medicines Agency
Serbia: Agency for Drugs and Medicinal Devices
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014