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Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01045447
First received: January 8, 2010
Last updated: February 24, 2011
Last verified: October 2010
History of Changes
  Purpose

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral antidiabetic drugs (OADs). Subjects will continue their ongoing treatment with OADs (oral anti-diabetic drugs) in the trial.


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, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

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: 465
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN5401 Drug: NN5401
NN5401 injected subcutaneously (under the skin) once daily with main meal. The dose will be individually adjusted.
Active Comparator: Insulin glargine Drug: insulin glargine
Insulin glargine 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:

  • Type 2 diabetes mellitus for at least 6 months
  • Ongoing daily treatment with a basal insulin (insulin detemir, insulin glargine, or insulin NPH) once daily for at least 3 months
  • Ongoing treatment with metformin with our without other OADs (oral anti-diabetic drugs) for at least 3 months
  • HbA1c 7.0 - 10.0 % (both inclusive)
  • BMI (Body Mass Index) at most 40.0 kg/m2

Exclusion Criteria:

  • Treatment with other insulin regimens than those listed in key inclusion criterion within the last 3 months
  • Treatment with rosiglitazone, or GLP-1 receptor agonists within the last 3 months
  • Significant 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
  • Impaired liver or renal function
  • Cancer and medical history of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045447

  Show 32 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Chris Lambert, B.S.Pharmacy 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: NCT01045447     History of Changes
Other Study ID Numbers: NN5401-3593, U1111-1111-7226, 2008-005767-34
Study First Received: January 8, 2010
Last Updated: February 24, 2011
Health Authority: Croatia: Ministry of Health and Social Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Ministry of Health
Poland: Ministry of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Turkey: 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
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013