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Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjets With Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01272193
First received: January 6, 2011
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

This trial is conducted in Japan. The aim of the trial is to investigate the efficacy and safety of NN5401 with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial OADs, subjects will continue at the same dose and dosing frequency.


Condition Intervention Phase
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™: JAPAN)

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:
  • Prandial plasma glucose (PG) increment at dinner of the day (90 min. after start of dinner as measured by self-monitored plasma glucose (SMPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]

Enrollment: 296
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN5401
Individually adjusted NN5401 injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).
Active Comparator: B Drug: insulin glargine
Individually adjusted insulin glargine administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • HbA1c 7.0-10.0% (both inclusive)
  • BMI below or equal to 35.0 kg/m^2
  • Insulin naive subject and ongoing treatment with 1 or more OADs for at least 12 weeks prior to randomisation (visit 2/week 0) with at least recommended maintenance dose according to local, approved labelling.

Exclusion Criteria:

  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (Mono Amino Oxidase) inhibitors
  • Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation (visit 2/week 0)
  • Cardiovascular disease within the last 6 months prior to screening (visit 1)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272193

Locations
Japan
Tagajo-shi, Japan, 985 0852
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Camilla Møntegaard 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: NCT01272193     History of Changes
Other Study ID Numbers: NN5401-3896, U1111-1118-0124, 111385
Study First Received: January 6, 2011
Last Updated: January 17, 2012
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

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