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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01068678
First received: February 12, 2010
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

This trial will be conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare NN1250 with insulin glargine in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN1250
Drug: insulin glargine
 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 Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)

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:
  • Body weight change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 460
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
NN1250 will be injected subcutaneously (under the skin) three times weekly. The dose will be individually adjusted.
Active Comparator: B Drug: insulin glargine
Insulin glargine will be injected subcutaneously (under the skin) once daily. 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:

  • Insulin naïve subjects
  • Currently treated with metformin alone or metformin combined with OADs (oral anti-diabetic drugs): insulin secretagogue (sulfonylurea (SU) or glinide), insulin DPP-4 inhibitor, a-glucosidase-inhibitor with unchanged dosing for at least three months prior to trial start
  • HbA1c: 7.0-10.0 % (both inclusive)
  • BMI (Body Mass Index) below or equal to 45.0 kg/m2

Exclusion Criteria:

  • Treatment with thiazoledinediones, exenatide or liraglutide within the last 3 months before trial start
  • Cardiovascular disease within the last 6 months prior to trial start
  • Uncontrolled treated/untreated severe hypertension
  • Pregnant, breast-feeding, intention of becoming pregnant or not using adequate contraceptive methods
  • Cancer and medical history of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068678

  Show 61 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Dorthe Lyngsoe Vuylsteke 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: NCT01068678     History of Changes
Other Study ID Numbers: NN1250-3724, 2009-011398-33, U1111-1113-2412
Study First Received: February 12, 2010
Last Updated: September 22, 2011
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Israel: Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013