A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01513590
First received: January 16, 2012
Last updated: March 6, 2013
Last verified: February 2013
  Purpose

This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec/insulin aspart
Drug: biphasic insulin aspart 30
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 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ 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 nocturnal (00:01-05:59 am) severe or minor hypoglycaemic episodes [ Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product ] [ Designated as safety issue: No ]
  • Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Responder for HbA1c (below 7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment including only subjects exposed for at least 12 weeks [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent AEs (adverse events) [ Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product ] [ Designated as safety issue: No ]

Enrollment: 394
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp Drug: insulin degludec/insulin aspart
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued
Active Comparator: BIAsp 30 Drug: biphasic insulin aspart 30
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued

  Eligibility

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

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks
  • Current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
  • Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days
  • Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
  • HbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 12 weeks prior to visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
  • Anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
  • Cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513590

Locations
Algeria
Algiers, Algeria, 16000
Bulgaria
Sofia, Bulgaria, 1606
Croatia
Zagreb, Croatia, 10000
Czech Republic
Praha, Czech Republic, 100 00
Germany
Völklingen, Germany, 66333
Poland
Warszawa, Poland, 02-507
Romania
Bucharest, Romania, 020614
Slovakia
Bratislava, Slovakia, 821 02
Turkey
Antalya, Turkey, 07058
Ukraine
Kiev, Ukraine, 04114
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Anne Juul Engstrøm Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01513590     History of Changes
Other Study ID Numbers: NN5401-3940, 2011-001712-61, U1111-1120-5633
Study First Received: January 16, 2012
Last Updated: March 6, 2013
Health Authority: Algeria: Ministry of Health
Bulgaria: Ministry of Health
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Turkey: Ministry of Health
Ukraine: Ministry of Health Ukraine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Hypoglycemic Agents
Metformin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014