Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens (BOOST™)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01365507
First received: May 31, 2011
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) in combination with metformin.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: IDegAsp |
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 Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE) |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Percentage 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 FPG (fasting plasma glucose) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
- Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks -1-27 ] [ Designated as safety issue: No ]
- Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-27 ] [ Designated as safety issue: No ]
| Enrollment: | 276 |
| Study Start Date: | June 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Titration algorithm A |
Drug: IDegAsp
IDegAsp injected subcutaneously (under the skin) once daily. Dose individually adjusted.
|
| Experimental: Titration algorithm B |
Drug: IDegAsp
IDegAsp injected subcutaneously (under the skin) once daily. Dose 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 (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
- Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
- Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
- HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
- BMI (Body Mass Index) below or equal to 45 kg/m^2
- Ability and willingness to adhere to the protocol including self measurement of plasma glucose
Exclusion Criteria:
- Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
- Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
- Known or suspected hypersensitivity to trial products or related products
- The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
- Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365507
Show 30 Study Locations
Show 30 Study LocationsSponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Anne Marie Valentin Jensen | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01365507 History of Changes |
| Other Study ID Numbers: | NN5401-3844, U1111-1117-0558, 2010-022306-40 |
| Study First Received: | May 31, 2011 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Malaysia: Drug Control Authority (DCA) Mexico: National Institute of Public Health, Health Secretariat South Korea: Korea Food and Drug Administration (KFDA) Thailand: Ministry of Public Health Turkey: Ministry of Health Drug and Pharmaceutical Department United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin aspart Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013