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Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01326026
First received: March 29, 2011
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN1250
 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 Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (AEs) [ Time Frame: weeks 0-26 ] [ Designated as safety issue: No ]
  • Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: weeks 0-26 ] [ Designated as safety issue: No ]

Enrollment: 222
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN1250 - simple titration algorithm Drug: NN1250
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Experimental: NN1250 - stepwise titration algorithm Drug: NN1250
Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.

  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Treatment with oral antidiabetic drugs (OADs) for at least 12 weeks before trial start at an unchanged dose
  • HbA1c: 7.0-10.0%
  • BMI (Body Mass Index) no higher than 45.0 kg/m2

Exclusion Criteria:

  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to randomisation (Visit 2)
  • Suffer from a life threatening disease (e.g. cancer)
  • Females of childbearing potential who are pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326026

  Show 30 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Nanna F. Mortensen, 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: NCT01326026     History of Changes
Other Study ID Numbers: NN1250-3846, U1111-1117-0616, 2010-022337-29
Study First Received: March 29, 2011
Last Updated: January 17, 2012
Health Authority: Finland: Finnish Medicines Agency Fimea
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013