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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01079234
First received: March 2, 2010
Last updated: November 27, 2015
Last verified: November 2015

March 2, 2010
November 27, 2015
March 2010
November 2010   (final data collection date for primary outcome measure)
  • Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 26 weeks of treatment
  • Extension Trial (Primary 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.
  • Extension Trial (Primary 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 occurring between 00:01 and 05:59 a.m.
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01079234 on ClinicalTrials.gov Archive Site
  • Extension Trial (Secondary 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.
  • Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
    Change from baseline in FPG after 26 weeks of treatment
  • Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
    Change from baseline in FPG after 52 weeks of treatment.
  • Change in FPG (fasting plasma glucose) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes
A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)
This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin degludec
    Injected subcutaneously (under the skin) once daily
  • Drug: insulin glargine
    Insulin glargine injected subcutaneously (under the skin) once daily
  • Drug: insulin aspart
    At least three daily doses at meal-time
  • Experimental: Flex + insulin aspart
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin aspart
  • Experimental: Fixed + insulin aspart
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin aspart
  • Active Comparator: IGlar + insulin aspart
    Interventions:
    • Drug: insulin glargine
    • Drug: insulin aspart

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
493
May 2011
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
  • Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
  • HbA1c maximum 10.0 % by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
  • Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
  • Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Germany,   Norway,   Poland,   United Kingdom
Greece
 
NCT01079234
NN1250-3770, U1111-1112-8813, 2009-012923-27
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP