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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01079234
First received: March 2, 2010
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

This trial is conducted in Europe and in the United States of America (USA). The aim of the trial is to investigate the efficacy and safety of NN1250 in subjects with type 1 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: NN1250
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: A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes - With a 26 Week Extension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 493
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
NN1250 injected subcutaneously (under the skin) once daily (alternative regimens)
Drug: insulin aspart
At least three daily doses at meal-time
Active Comparator: B Drug: insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily
Drug: insulin aspart
At least three daily doses at meal-time
Experimental: C Drug: NN1250
NN1250 injected subcutaneously (under the skin) once daily
Drug: insulin aspart
At least three daily doses at meal-time

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 using one or two daily injections and with three or more daily meal-time insulin injections used as bolus insulin therapy
  • HbA1c below or equal to 10.0 %
  • BMI (Body Mass Index) below or equal to 35.0 kg/m2
  • Ability to self-manage insulin therapy of a changed insulin dose in the preceding two months prior to trial entry
  • Ability and willingness to adhere to the protocol including performance of SMPG (self-measured plasma glucose) profiles and self-adjustment of insulin doses

Exclusion Criteria:

  • Use of any antidiabetic glucose lowering drug other than insulin within the last 3 months prior to trial entry
  • Cardiovascular disease within the last 6 months prior to trial entry
  • Uncontrolled treated/untreated severe hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
  • Cancer and medical history of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079234

  Show 43 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Anette Skov Pedersen Novo Nordisk
  More Information

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01079234     History of Changes
Other Study ID Numbers: NN1250-3770, U1111-1112-8813, 2009-012923-27
Study First Received: March 2, 2010
Last Updated: December 8, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Poland: The Drug Institute in Warsaw
Greece: Ministry of Health

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
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013