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Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01045707
First received: January 8, 2010
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

This trial will be conducted in Asia, Europe and the United states of America (USA).

The aim of this clinical trial is to compare NN5401 with insulin glargine, as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug) in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: NN5401
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 NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1)

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:
  • Plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 530
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN5401
Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.
Active Comparator: B Drug: insulin glargine
Injected s.c. (under the skin) once daily. Dose was individually adjusted.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus for at least 6 months
  • Insulin naïve subjects
  • Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
  • Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
  • Body Mass Index (BMI) no higher than 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
  • Cardiovascular disease diagnosed within 6 months before trial start
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045707

  Show 46 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lotte Askevig, M.Sc.Pharm 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: NCT01045707     History of Changes
Other Study ID Numbers: NN5401-3590, 2009-011271-78, U1111-1111-7178
Study First Received: January 8, 2010
Last Updated: April 23, 2013
Health Authority: Austria: Federal Ministry for Health and Women
India: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Drug Agency and Medicinal Products
Turkey: Ministry of Health
Poland: Ministry of Health
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 23, 2013