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:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01513590
First received: January 16, 2012
Last updated: March 6, 2013
Last verified: February 2013
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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:
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
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
Investigators
| Study Director: | Anne Juul Engstrøm | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| 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 aspart |
Insulin Hypoglycemic Agents Metformin Insulin, NPH Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013