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Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00972283
First received: September 3, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

This trial was conducted in Africa, Asia, Europe, and the United States of America (USA).

The aim of this clinical trial was to compare NN1250 (insulin degludec, IDeg) with insulin glargine plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.

Main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: insulin glargine
Drug: insulin aspart
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: NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)

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 78 + 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 78 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 78 + 7 days follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) after 78 Weeks of Treatment [ Time Frame: Week 0, Week 78 ] [ 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 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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: 1006
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg OD
Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
Drug: insulin degludec
Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.
Experimental: IGlar OD
Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
Drug: insulin glargine
Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) at each main meal. 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:

  • For MAIN period (NN1250-3582):
  • Type 2 diabetes mellitus for at least 6 months
  • Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
  • HbA1c 7.0-10.0 % (both inclusive)
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2
  • For EXTENSION period (NN1250-3667):
  • Completion of the 52 week treatment period in NN1250-3582

Exclusion Criteria:

  • For MAIN period (NN1250-3582):
  • Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
  • 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: NCT00972283

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35209
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Goodyear, Arizona, United States, 85395
Novo Nordisk Clinical Trial Call Center
Peoria, Arizona, United States, 85381
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Los Gatos, California, United States, 95032
Novo Nordisk Clinical Trial Call Center
Salinas, California, United States, 93901
Novo Nordisk Clinical Trial Call Center
Santa Monica, California, United States, 90404
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Connecticut
Novo Nordisk Clinical Trial Call Center
Waterbury, Connecticut, United States, 06712
United States, Florida
Novo Nordisk Clinical Trial Call Center
Gainesville, Florida, United States, 32610
Novo Nordisk Clinical Trial Call Center
Lake Mary, Florida, United States, 32746
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
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, 30339
Novo Nordisk Clinical Trial Call Center
Fort Valley, Georgia, United States, 31030-5008
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Nampa, Idaho, United States, 83686-6011
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47714
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46217
Novo Nordisk Clinical Trial Call Center
New Albany, Indiana, United States, 47150
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70006-2930
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
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, Missouri
Novo Nordisk Clinical Trial Call Center
Jefferson City, Missouri, United States, 65109
Novo Nordisk Clinical Trial Call Center
Jefferson City, Missouri, United States, 65109-6001
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63104
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Lincoln, Nebraska, United States, 68521
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68114
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89117
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, North Carolina
Novo Nordisk Clinical Trial Call Center
Charlotte, North Carolina, United States, 28209
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Danville, Pennsylvania, United States, 17822
Novo Nordisk Clinical Trial Call Center
Kingston, Pennsylvania, United States, 18704
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Clinical Trial Call Center
Willkes Barre, Pennsylvania, United States, 18711-3713
United States, South Carolina
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
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Corpus Christi, Texas, United States, 78412
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
Fort Worth, Texas, United States, 76113
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Novo Nordisk Clinical Trial Call Center
Round Rock, Texas, United States, 78681
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
United States, Washington
Novo Nordisk Clinical Trial Call Center
Olympia, Washington, United States, 98502
Novo Nordisk Clinical Trial Call Center
Renton, Washington, United States, 98057
Bulgaria
Sofia, Bulgaria, 1606
Germany
Völklingen, Germany, 66333
Hong Kong
Hong Kong, Hong Kong
Ireland
Dublin, Ireland
Italy
Roma, Italy, 00161
Romania
Timisoara, Romania, 300736
Russian Federation
Barnaul, Russian Federation, 656045
Slovakia
Lucenec, Slovakia, 984 01
South Africa
Pretoria, Gauteng, South Africa, 0001
Spain
Madrid, Spain, 28040
Turkey
Istanbul, Turkey, 34098
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Malene Bording Krüger, B.Sc Novo Nordisk A/S
Study Director: Winnie Søjborg Pedersen 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: NCT00972283     History of Changes
Obsolete Identifiers: NCT01193322
Other Study ID Numbers: NN1250-3582, 2008-005777-35, U1111-1111-8648, 2009-015816-17, U1111-1114-9067
Study First Received: September 3, 2009
Last Updated: November 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Ireland: Irish Medicines Board
Spain: Spanish agency of medicines and health care products
South Africa: Medicines Control Council
Hong Kong: Department of Health
Russia: Federal Service for Control of Health Care and Social Development
Turkey: Ministry of Health Drug and Pharmaceutical Department
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 Aspart
Insulin, Globin Zinc
Insulin, Long-Acting
Metformin
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014