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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:
NCT01068665
First received: February 12, 2010
Last updated: March 22, 2011
Last verified: December 2010
History of Changes
  Purpose

This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of 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) 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™: LOW VOLUME)

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:
  • FPG (fasting plasma glucose) change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: March 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) once daily.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 subject
  • Treated with metformin alone or metformin in any combination with insulin secretagogues, DPP-4 inhibitor, a-glucosidase-inhibitor for at least 3 months prior to trial start
  • HbA1c between 7.0-10.0 % (both inclusive)
  • BMI (Body Mass Index) below or equal to 45.0 kg/m2
  • Type 2 diabetes for at least 6 months
  • Able and willing to self monitor subject's own plasma glucose (SMPG) profile

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 prior to trial start
  • 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: NCT01068665

  Show 62 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Trine Danø Klingberg 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: NCT01068665     History of Changes
Other Study ID Numbers: NN1250-3672, 2009-010662-28, U1111-1112-8977
Study First Received: February 12, 2010
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
South Africa: Medicines Control Council
Canada: Health Canada
Russia: Federal Service for Control of Health Care and Social Development

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 19, 2013