Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir 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:
NCT01074268
First received: February 22, 2010
Last updated: November 28, 2013
Last verified: November 2013

February 22, 2010
November 28, 2013
February 2010
December 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 ]
  • Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01074268 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 ]
  • Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Extension 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 ]
  • 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 ]
  • 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 ]
  • Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 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 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension 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 ]
  • Fasting plasma glucose (FPG) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 26 weeks of treatment. ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: over 26 weeks of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)

This trial is conducted in Asia, Europe, Japan and South America.

The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (IDeg)) with insulin detemir (IDet), both combined with insulin aspart.

Main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

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 s.c. (under the skin) once daily. Dose was individually adjusted.
  • Drug: insulin detemir
    Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.
  • Drug: insulin aspart
    Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
  • Experimental: IDeg OD
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin aspart
  • Active Comparator: IDet
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
456
June 2011
December 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%
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • For Japan only: Minimum age is 20 years
  • For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

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
  • Cancer and medical history of cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Finland,   India,   Italy,   Japan,   Macedonia, The Former Yugoslav Republic of,   United Kingdom
Argentina
 
NCT01074268
NN1250-3585, 2009-011672-29, U1111-1111-7249, JapicCTI-101067, 2009-015721-36, U1111-1114-9479, JapicCTI-22-0677
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