A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02906917
• Date of registration: 15/09/2016
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
• Scientific title: This Trial is Conducted Globally. The Aim of This Trial is to Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification.
• Date of first enrolment: September 20, 2016
• Target sample size: 532
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02906917
• 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, Czech Republic, Czechia, India, Russian Federation, Serbia, Turkey, United States

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 procedures that are carried out as part of the trial, including
activities to determine suitability for the trial

- Male or female, age at least 18 years at the time of signing informed consent Algeria:
Male or female, age at least 19 years at the time of signing informed consent

- Diagnosed with type 2 diabetes mellitus

- Treated with any basal insulin for at least 90 days prior to the day of screening

- Subject not on any OAD(s) prior to trial participation OR subjects on stable daily
dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s)
include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metformin
at least 1500 mg or maximum tolerated dose documented in the subject medical record)
b. Other OADs (at least half of the maximum approved dose according to local label or
maximum tolerated dose as documented in subject medical record): i. Insulin
secretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii.
a-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v.
Oral combination products (of the allowed individual OADs above)

- HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis

- Body mass index (BMI) equal to or below 45.0 kg/m^2

Exclusion Criteria:

- Participation in any clinical trial of an approved or non-approved investigational
medicinal product within four weeks prior to the day of screening (V1)

- Any chronic disorder or severe disease which, in the opinion of the investigator,
might jeopardise subject's safety or compliance with the protocol

- Acute decompensation of glycaemic control requiring immediate intensification of
treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal
or below 90 days prior to the day of the screening and between screening and
randomisation

- Any of the following: myocardial infarction, stroke or hospitalization for unstable
angina or transient ischaemic attack within the past 180 days prior to the day of
screening and between screening and randomisation

- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of
below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope
dilution mass spectrometry (IDMS) for serum creatinine measured at screening

- Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above
2.5 times upper normal limit (UNL) at screening.

- Subjects presently classified as being in New York Heart Association (NYHA) Class IV

- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria in a period of 90 days before the day of screening

- Anticipated initiation or change in concomitant medications (for more than 14
consecutive days) known to affect weight or glucose metabolism (e.g. treatment with
orlistat, thyroid hormones, or corticosteroids)



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

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Insulin degludec/insulin aspart

Drug: Insulin glargine

Drug: Insulin aspart

Primary Outcome(s)

Change in HbA1c (%) - Week 26 [Time Frame: Week 0, week 26]

Secondary Outcome(s)

Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [Time Frame: Weeks 0-26, weeks 16-26, weeks 0-38]

Change in Pre-breakfast SMPG (Used for Titration) [Time Frame: Week 1, week 26, week 38]

Total Insulin Dose [Time Frame: Week 26 and week 38]

Change in Body Weight [Time Frame: Week 0, week 26, week 38]

Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia [Time Frame: Week 26 and week 38]

Responder (Yes/No) for HbA1c < 7% [Time Frame: Week 26 and week 38]

Change in HbA1c (%) - Week 38 [Time Frame: Week 0, week 38]

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [Time Frame: Weeks 0-26, weeks 16-26, weeks 0-38]

Change in FPG [Time Frame: Week 0, week 26, week 38]

Change in Postprandial SMPG Increment (From 9-point Profile) [Time Frame: Week 0, week 26, week 38]

Incidence of TEAEs [Time Frame: Weeks 0-26, weeks 26-38, weeks 0-38]

Secondary ID(s)

U1111-1175-7895

2015-004768-12

NN5401-4266

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02906917