Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00982228
First received: September 22, 2009
Last updated: November 24, 2015
Last verified: November 2015
  Purpose

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

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
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: NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, 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 in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

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 ]
    Change from baseline in HbA1c after 52 weeks of treatment

  • Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 104 + 7 days follow up ] [ Designated as safety issue: No ]
    Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: 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.

  • 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 ]
    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): Cross-reacting Antibodies to Human Insulin [ Time Frame: Week 0, Week 106 ] [ Designated as safety issue: No ]
    The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.


Secondary Outcome Measures:
  • 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 ]
    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 occuring between 00:01 and 05:59 a.m.

  • 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 ]
    Change from baseline in HbA1c after 104 weeks of treatment

  • Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment [ Time Frame: Treatment week 104 ] [ Designated as safety issue: No ]
    Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 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.

  • 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 ]
    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 ] [ Designated as safety issue: No ]
    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 occuring between 00:01 and 05:59 a.m.

  • 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 ]
    Mean of 9-point self-measured plasma glucose profile (SMPG) after 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.


Enrollment: 629
Study Start Date: September 2009
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg OD Drug: insulin degludec
Injected subcutaneously once daily. Dose was individually adjusted.
Drug: insulin aspart
Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
Active Comparator: IGlar OD Drug: insulin glargine
Injected subcutaneously once daily. Dose individually adjusted.
Drug: insulin aspart
Injected subcutaneously as mealtime insulin. Dose was individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months
  • Current treatment with any basal bolus insulin for at least 12 months
  • HbA1c below or equal to 10.0%
  • BMI (Body Mass Index) below or equal to 35.0 kg/m^2
  • For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)

Exclusion Criteria:

  • Use of any other antidiabetic drug than insulin within the last 3 months
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • 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: NCT00982228

  Show 64 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00982228     History of Changes
Obsolete Identifiers: NCT01198041
Other Study ID Numbers: NN1250-3583  2008-005774-13  U1111-1111-8789  2009-015755-24  U1111-1116-1578 
Study First Received: September 22, 2009
Results First Received: October 14, 2015
Last Updated: November 24, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council
United States: Food and Drug Administration
Russia: Federal Service for Control of Health Care and Social Development

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2016