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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01513590
• Date of registration: 16/01/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes BOOST™
• Scientific 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)
• Date of first enrolment: January 16, 2012
• Target sample size: 394
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01513590
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Algeria, Bulgaria, Croatia, Czech Republic, Czechia, Germany, Poland, Romania, Slovakia, Turkey, Ukraine

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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 prior to
screening

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Diabetes

Intervention(s)

Drug: insulin degludec/insulin aspart

Primary Outcome(s)

Change From Baseline in HbA1c (Glycosylated Haemoglobin) [Time Frame: Week 0, week 26]

Secondary Outcome(s)

Change From Baseline in Fasting Plasma Glucose (FPG) [Time Frame: Week 0, week 26]

Change From Baseline in Body Weight [Time Frame: Week 0, week 26]

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]

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]

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]

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]

Secondary ID(s)

U1111-1120-5633

2011-001712-61

NN5401-3940

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/11/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01513590