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 28, 2013
Last verified: November 2013

September 22, 2009
November 28, 2013
September 2009
November 2010   (final data collection date for primary outcome measure)
  • 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 Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 104 + 7 days follow up ] [ 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 ]
  • Cross-reacting Antibodies to Human Insulin [ Time Frame: Week 0, Week 106 ] [ Designated as safety issue: No ]
HbA1c change from baseline [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00982228 on ClinicalTrials.gov Archive Site
  • 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 (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment [ Time Frame: Week 0, Week 104 ] [ 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 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 ]
  • 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 ]
  • Number of hypoglycaemic episodes [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Plasma glucose profiles [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
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)

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.

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

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 once daily. Dose was individually adjusted.
  • Drug: insulin glargine
    Injected subcutaneously once daily. Dose individually adjusted.
  • Drug: insulin aspart
    Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
  • Experimental: IDeg OD
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin aspart
  • Active Comparator: IGlar OD
    Interventions:
    • Drug: insulin glargine
    • Drug: insulin aspart
Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L, Renard E, Russell-Jones D, Philotheou A, Francisco AM, Pei H, Bode B; BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1489-97. doi: 10.1016/S0140-6736(12)60204-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
629
November 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Russian Federation,   South Africa,   United Kingdom
 
NCT00982228
NN1250-3583, 2008-005774-13, U1111-1111-8789, 2009-015755-24, U1111-1116-1578
No
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 2013

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