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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
ClinicalTrials.gov Identifier:
NCT01074268
First received: February 22, 2010
Last updated: September 15, 2011
Last verified: September 2011
History of Changes
  Purpose

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare NN1250 with insulin detemir, both combined with insulin aspart, in patients with type 1 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: NN1250
Drug: insulin detemir
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: 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 (BEGIN™: BB T1)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 456
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
NN1250 injected subcutaneously (under the skin) once daily.The dose will be individually adjusted.
Drug: insulin aspart
Insulin aspart injected subcutaneously (under the skin) as mealtime insulin.The dose will be individually adjusted.
Active Comparator: B Drug: insulin detemir
Insulin detemir injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
Drug: insulin aspart
Insulin aspart injected subcutaneously (under the skin) as mealtime insulin.The dose will be individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older
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/m2
  • For Japan only: Minimum age is 20 years

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074268

Locations
Brazil
Sao Paulo, Brazil, 04022-001
Finland
Kuopio, Finland, 70210
India
Mysore, Karnataka, India, 560023
Italy
Milano, Italy, 20162
Japan
Sapporo-shi, Japan, 060 0062
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
United Kingdom
Bath, United Kingdom, BA1 2RG
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Heidi V. Nielsen, M.Sc. Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01074268     History of Changes
Other Study ID Numbers: NN1250-3585, U1111-1111-7249, 2009-011672-29, 101067
Study First Received: February 22, 2010
Last Updated: September 15, 2011
Health Authority: Brazil: National Health Surveillance Agency
Finland: Finnish Medicines Agency
India: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013