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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: March 8, 2017
Last verified: March 2017
  Purpose

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

The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) 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.

The 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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Change from baseline in HbA1c after 52 weeks of treatment

  • Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 78 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

  • Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 78 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 78 + 7 days follow up ]
    Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.


Secondary Outcome Measures:
  • Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment [ Time Frame: Week 0, Week 78 ]
    Change from baseline in HbA1c after 78 weeks of treatment

  • Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 [ Time Frame: Week 52 ]
    Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

  • Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78 [ Time Frame: Week 78 ]
    Mean of the SMPG at 78 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am, before breakfast.

  • Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

  • Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.


Enrollment: 1006
Actual Study Start Date: September 1, 2009
Study Completion Date: October 28, 2010
Primary Completion Date: October 28, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg OD 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.
Active Comparator: IGlar OD 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   (Adult, Senior)
Sexes Eligible for Study:   All
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 Investigational Site
Alexander City, Alabama, United States, 35010
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92648
Novo Nordisk Investigational Site
Los Gatos, California, United States, 95032
Novo Nordisk Investigational Site
Salinas, California, United States, 93901
Novo Nordisk Investigational Site
Santa Monica, California, United States, 90404
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Connecticut
Novo Nordisk Investigational Site
Milford, Connecticut, United States, 06460
Novo Nordisk Investigational Site
Norwalk, Connecticut, United States, 06851
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States, 06712
United States, District of Columbia
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20060
United States, Florida
Novo Nordisk Investigational Site
Gainesville, Florida, United States, 32610
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32205
Novo Nordisk Investigational Site
Lake Mary, Florida, United States, 32746
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32804
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33324
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Fort Valley, Georgia, United States, 31030-5008
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Investigational Site
Nampa, Idaho, United States, 83686-6011
United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47714
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46217
Novo Nordisk Investigational Site
New Albany, Indiana, United States, 47150
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70006-2930
United States, Maryland
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
Novo Nordisk Investigational Site
North East, Maryland, United States, 21901
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Minnesota
Novo Nordisk Investigational Site
Eagan, Minnesota, United States, 55123
United States, Missouri
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States, 65109
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63104
United States, Nebraska
Novo Nordisk Investigational Site
Lincoln, Nebraska, United States, 68521
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89117
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, North Carolina
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28209
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43203
Novo Nordisk Investigational Site
Toledo, Ohio, United States, 43606-2920
United States, Pennsylvania
Novo Nordisk Investigational Site
Danville, Pennsylvania, United States, 17822
Novo Nordisk Investigational Site
Kingston, Pennsylvania, United States, 18704
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, United States, 19027
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Investigational Site
Wilkes Barre, Pennsylvania, United States, 18711
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29455
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
Novo Nordisk Investigational Site
Newberry, South Carolina, United States, 29108-2249
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Corpus Christi, Texas, United States, 78412
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76113
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23233
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
Novo Nordisk Investigational Site
Renton, Washington, United States, 98057
Bulgaria
Novo Nordisk Investigational Site
Dimitrovgrad, Bulgaria, 6400
Novo Nordisk Investigational Site
Ruse, Bulgaria, 7000
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1233
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1431
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
Novo Nordisk Investigational Site
Stara Zagora, Bulgaria, 6000
Novo Nordisk Investigational Site
Varna, Bulgaria, 9010
Germany
Novo Nordisk Investigational Site
Dresden, Germany, 01219
Novo Nordisk Investigational Site
Dresden, Germany, 01307
Novo Nordisk Investigational Site
Frankfurt, Germany, 60388
Novo Nordisk Investigational Site
Hamburg, Germany, 22587
Novo Nordisk Investigational Site
Ludwigshafen, Germany, 67059
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Novo Nordisk Investigational Site
Wangen, Germany, 88239
Novo Nordisk Investigational Site
Warburg, Germany, 34414
Hong Kong
Novo Nordisk Investigational Site
Shatin, New Territories, Hong Kong
Ireland
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 15
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 7
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 8
Novo Nordisk Investigational Site
Dublin, Ireland
Italy
Novo Nordisk Investigational Site
Bari, Italy, 70124
Novo Nordisk Investigational Site
Bergamo, Italy, 24127
Novo Nordisk Investigational Site
Catania, Italy, 95124
Novo Nordisk Investigational Site
Chieti Scalo, Italy, 66100
Novo Nordisk Investigational Site
Firenze, Italy, 50141
Novo Nordisk Investigational Site
Foggia, Italy, 71100
Novo Nordisk Investigational Site
Gazi, Italy, 98124
Novo Nordisk Investigational Site
Messina, Italy, 98123
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
Perugia, Italy, 06126
Novo Nordisk Investigational Site
Pisa, Italy, 56100
Novo Nordisk Investigational Site
Roma, Italy, 00161
Novo Nordisk Investigational Site
Torino, Italy, 10126
Romania
Novo Nordisk Investigational Site
Baia Mare, Maramures, Romania, 430123
Novo Nordisk Investigational Site
Bucharest, Romania, 011234
Novo Nordisk Investigational Site
Constanta, Romania, 900591
Novo Nordisk Investigational Site
Suceava, Romania, 720237
Novo Nordisk Investigational Site
Timisoara, Romania, 300736
Russian Federation
Novo Nordisk Investigational Site
Arkhangelsk, Russian Federation, 163001
Novo Nordisk Investigational Site
Barnaul, Russian Federation, 656045
Novo Nordisk Investigational Site
Krasnoyarsk, Russian Federation, 660022
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119435
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125367
Novo Nordisk Investigational Site
Perm, Russian Federation, 614990
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site
Yaroslavl, Russian Federation, 150003
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 82102
Novo Nordisk Investigational Site
Bratislava, Slovakia, 851 01
Novo Nordisk Investigational Site
Bratislava, Slovakia, 851 05
Novo Nordisk Investigational Site
Lucenec, Slovakia, 984 01
South Africa
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0181
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4450
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Bloemfontein, South Africa, 9301
Spain
Novo Nordisk Investigational Site
Alcorcón, Spain, 28922
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Hospitalet de Llobregat, Spain, 08907
Novo Nordisk Investigational Site
La Coruña, Spain, 15006
Novo Nordisk Investigational Site
Madrid, Spain, 28040
Novo Nordisk Investigational Site
Mostoles - Madrid -, Spain, 28935
Novo Nordisk Investigational Site
Sabadell, Spain, 08208
Novo Nordisk Investigational Site
San Juan, Spain, 03550
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Turkey
Novo Nordisk Investigational Site
Antalya, Turkey, 07058
Novo Nordisk Investigational Site
Istanbul, Turkey, 34098
Novo Nordisk Investigational Site
Istanbul, Turkey, 34390
Novo Nordisk Investigational Site
Mersin, Turkey, 33070
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

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 ( EudraCT Number )
U1111-1111-8648 ( Other Identifier: WHO )
2009-015816-17 ( EudraCT Number )
U1111-1114-9067 ( Other Identifier: WHO )
Study First Received: September 3, 2009
Results First Received: October 14, 2015
Last Updated: March 8, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Pioglitazone
Insulin degludec, insulin aspart drug combination
Insulin
Metformin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017