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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01076647
First received: February 25, 2010
Last updated: February 23, 2011
Last verified: January 2011
History of Changes
  Purpose

This trial is conducted in Europe and North America. The aim of this clinical trial is to compare NN1250 with insulin glargine, as add-on to subject's ongoing treatment with metformin and/or DPP-4 inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).


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 the Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (EASY™)

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: 467
Study Start Date: March 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 will be injected subcutaneously (under the skin) once daily three times weekly
Active Comparator: B Drug: insulin glargine
Insulin glargine will be injected subcutaneously (under the skin) once daily administered at the same time each day

  Eligibility

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

Inclusion Criteria:

  • The subjects must be diagnosed with type 2 diabetes mellitus for at least 6 months
  • Insulin naïve subjects
  • Current treatment: metformin alone or metformin in any combination with other oral anti-diabetic drugs (OADs)
  • HbA1c between 7.0 and 10.0 % (both inclusive)
  • BMI (Body Mass Index) below or equal to 45.0 kg/m2

Exclusion Criteria:

  • Use of thiazoledinediones (TZDs), exenatide or liraglutide within the last 3 months prior to trial start
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • 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: NCT01076647

  Show 57 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Kirsten Jøns Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076647     History of Changes
Other Study ID Numbers: NN1250-3718, U1111-1112-8770, 2009-011399-31
Study First Received: February 25, 2010
Last Updated: February 23, 2011
Health Authority: Canada: Health Canada
Romania: National Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Bulgaria: Bulgarian Drug Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Hungary: National Institute of Pharmacy
United States: Institutional Review Board

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 June 17, 2013