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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02906917
Collaborator
(none)
532
71
2
15.1
7.5
0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Insulin degludec/insulin aspart
  • Drug: Insulin glargine
  • Drug: Insulin aspart
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
532 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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.
Actual Study Start Date :
Sep 20, 2016
Actual Primary Completion Date :
Aug 31, 2017
Actual Study Completion Date :
Dec 24, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: IDegAsp

Drug: Insulin degludec/insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.

Active Comparator: IGlar + IAsp

Drug: Insulin glargine
Administered subcutaneously (s.c. under the skin) once daily.

Drug: Insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c (%) - Week 26 [Week 0, week 26]

    Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation.

Secondary Outcome Measures

  1. Change in HbA1c (%) - Week 38 [Week 0, week 38]

    Change from baseline (week 0) in HbA1c was evaluated 38 weeks after randomisation.

  2. Responder (Yes/No) for HbA1c < 7% [Week 26 and week 38]

    Participants achieving (yes/no) HbA1c <7% was evaluated 26 and 38 weeks after randomisation, respectively.

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

    Participants achieving (yes/no) HbA1c <7% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia, was evaluated 26 and 38 weeks after randomisation, respectively. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

  4. Change in FPG [Week 0, week 26, week 38]

    Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated 26 and 38 weeks after randomisation, respectively.

  5. Change in Pre-breakfast SMPG (Used for Titration) [Week 1, week 26, week 38]

    Reported results are observed pre-breakfast self-measured plasma glucose (SMPG; used for titration) values at week 1 (baseline) and 26 and 38 weeks after randomisation.

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

    Change from baseline (week 0) in postprandial SMPG increment (from 9-point profile) was evaluated 26 and 38 weeks after randomisation, respectively. 9-point SMPG profiles were measured starting in the morning 2 days prior to the scheduled visit at the time points described below: 1) Before breakfast (2 days prior to visit) 2) 90 minutes after start of the breakfast 3) Before lunch 4) 90 minutes after start of the lunch 5) Before dinner/main evening meal 6) 90 minutes after start of the dinner/main evening meal 7) At bedtime (2 days or 1 day prior to visit depending on actual clock time) 8) At 4 a.m. (1 day prior to visit) 9) Before breakfast at the following day (1 day prior to the visit).

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

    Number of nocturnal, treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.

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

    Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.

  9. Total Insulin Dose [Week 26 and week 38]

    Total insulin dose was evaluated 26 and 38 weeks after randomisation, respectively.

  10. Change in Body Weight [Week 0, week 26, week 38]

    Change from baseline (week 0) in body weight was evaluated 26 and 38 weeks after randomisation, respectively.

  11. Incidence of TEAEs [Weeks 0-26, weeks 26-38, weeks 0-38]

    Number of treatment emergent adverse events (TEAEs) were analysed during the following periods: weeks 0-26, weeks 26-38 and weeks 0-38. Treatment emergent: An adverse event that had an onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. If an event had an onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period, or if it had an onset date within 7 days after the last drug date, then this event was also to be considered as a TEAE.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. 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. α-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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Glendale Arizona United States 85306-4652
2 Novo Nordisk Investigational Site Phoenix Arizona United States 85050
3 Novo Nordisk Investigational Site Anaheim California United States 92801
4 Novo Nordisk Investigational Site Concord California United States 94520
5 Novo Nordisk Investigational Site Fresno California United States 93720
6 Novo Nordisk Investigational Site La Jolla California United States 92037
7 Novo Nordisk Investigational Site Northridge California United States 91325
8 Novo Nordisk Investigational Site Danbury Connecticut United States 06810
9 Novo Nordisk Investigational Site Fort Lauderdale Florida United States 33312
10 Novo Nordisk Investigational Site Fort Lauderdale Florida United States 33316
11 Novo Nordisk Investigational Site Jacksonville Florida United States 32205
12 Novo Nordisk Investigational Site Kissimmee Florida United States 34744
13 Novo Nordisk Investigational Site Roswell Georgia United States 30076
14 Novo Nordisk Investigational Site Louisville Kentucky United States 40213
15 Novo Nordisk Investigational Site Chesterfield Missouri United States 63017
16 Novo Nordisk Investigational Site New York New York United States 10029
17 Novo Nordisk Investigational Site Westfield New York United States 14787
18 Novo Nordisk Investigational Site Wilmington North Carolina United States 28401
19 Novo Nordisk Investigational Site Franklin Ohio United States 45005
20 Novo Nordisk Investigational Site Bartlett Tennessee United States 38133
21 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37411
22 Novo Nordisk Investigational Site Kingsport Tennessee United States 37660
23 Novo Nordisk Investigational Site Knoxville Tennessee United States 37938
24 Novo Nordisk Investigational Site Nashville Tennessee United States 37228
25 Novo Nordisk Investigational Site Austin Texas United States 78758
26 Novo Nordisk Investigational Site Dallas Texas United States 75390-9302
27 Novo Nordisk Investigational Site San Antonio Texas United States 78230
28 Novo Nordisk Investigational Site Chesapeake Virginia United States 23321
29 Novo Nordisk Investigational Site Midlothian Virginia United States 23114
30 Novo Nordisk Investigational Site Winchester Virginia United States 22601-3834
31 Novo Nordisk Investigational Site Constantine Algeria 25000
32 Novo Nordisk Investigational Site Oran Algeria 31000
33 Novo Nordisk Investigational Site Sidi Bel Abbes Algeria 22000
34 Novo Nordisk Investigational Site Broumov Czechia 550 01
35 Novo Nordisk Investigational Site Nachod Czechia 547 01
36 Novo Nordisk Investigational Site Nachod Czechia 54701
37 Novo Nordisk Investigational Site Prague 4 Czechia 140 21
38 Novo Nordisk Investigational Site Praha 4 Czechia 140 46
39 Novo Nordisk Investigational Site Trutnov Czechia 541 01
40 Novo Nordisk Investigational Site Hyderabad Andhra Pradesh India 500001
41 Novo Nordisk Investigational Site Hyderabad Andhra Pradesh India 500072
42 Novo Nordisk Investigational Site Surat Gujarat India 395002
43 Novo Nordisk Investigational Site Kozhikode Kerala India 673017
44 Novo Nordisk Investigational Site Aurangabad Maharashtra India 431005
45 Novo Nordisk Investigational Site Mumbai Maharashtra India 400058
46 Novo Nordisk Investigational Site New Dehli New Delhi India 110029
47 Novo Nordisk Investigational Site Coimbatore Tamil Nadu India 641018
48 Novo Nordisk Investigational Site Kolkata West Bengal India 700054
49 Novo Nordisk Investigational Site New Delhi India 110001
50 Novo Nordisk Investigational Site Arkhangelsk Russian Federation 163045
51 Novo Nordisk Investigational Site Cheboksary Russian Federation 428009
52 Novo Nordisk Investigational Site Moscow Russian Federation 127486
53 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 191119
54 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 194354
55 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 195213
56 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 197762
57 Novo Nordisk Investigational Site Saratov Russian Federation 410039
58 Novo Nordisk Investigational Site Saratov Russian Federation 410053
59 Novo Nordisk Investigational Site Syktyvkar Russian Federation 167981
60 Novo Nordisk Investigational Site Tumen Russian Federation 625023
61 Novo Nordisk Investigational Site Belgrade Serbia 11000
62 Novo Nordisk Investigational Site Belgrade Serbia 11080
63 Novo Nordisk Investigational Site Nis Serbia 18000
64 Novo Nordisk Investigational Site Adana Turkey 01250
65 Novo Nordisk Investigational Site Ankara Turkey 06100
66 Novo Nordisk Investigational Site Ankara Turkey 06500
67 Novo Nordisk Investigational Site Istanbul Turkey 34098
68 Novo Nordisk Investigational Site Istanbul Turkey 34303
69 Novo Nordisk Investigational Site Istanbul Turkey 34718
70 Novo Nordisk Investigational Site Istanbul Turkey 34752
71 Novo Nordisk Investigational Site Izmir Turkey 35340

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02906917
Other Study ID Numbers:
  • NN5401-4266
  • 2015-004768-12
  • U1111-1175-7895
First Posted:
Sep 20, 2016
Last Update Posted:
Nov 13, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details The trial was conducted at 71 sites in 7 countries, as follows: Algeria (4), Czech Republic (6), India (10), Russian Federation (11), Serbia (5), Turkey (7), and United States (28). Additionally, 1 site in the United States screened, but didn't randomise any subject.
Pre-assignment Detail
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin degludec/insulin aspart (IDegAsp) once daily (OD) administered at the largest meal each day with or without oral antidiabetic drug(s) (OAD(s)). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/twice a day (BID) administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Period Title: Initiation Period (Week 0-26)
STARTED 267 265
Exposed 265 263
COMPLETED 261 254
NOT COMPLETED 6 11
Period Title: Initiation Period (Week 0-26)
STARTED 261 254
COMPLETED 252 247
NOT COMPLETED 9 7

Baseline Characteristics

Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart Total
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s). Total of all reporting groups
Overall Participants 267 265 532
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
58.2
(8.9)
59.2
(9.1)
58.7
(9.0)
Sex: Female, Male (Count of Participants)
Female
142
53.2%
128
48.3%
270
50.8%
Male
125
46.8%
137
51.7%
262
49.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
21
7.9%
20
7.5%
41
7.7%
Not Hispanic or Latino
246
92.1%
245
92.5%
491
92.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
0.4%
0
0%
1
0.2%
Asian
29
10.9%
32
12.1%
61
11.5%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
13
4.9%
11
4.2%
24
4.5%
White
221
82.8%
220
83%
441
82.9%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
3
1.1%
2
0.8%
5
0.9%

Outcome Measures

1. Primary Outcome
Title Change in HbA1c (%) - Week 26
Description Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation.
Time Frame Week 0, week 26

Outcome Measure Data

Analysis Population Description
FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 267 265
Baseline (week 0)
8.2
(0.8)
8.1
(0.7)
Change from baseline (week 26)
-1.1
(0.9)
-1.1
(0.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Degludec/Insulin Aspart, Insulin Glargine + Insulin Aspart
Comments The response and change from baseline in response are analysed on 1000 complete, imputed data sets after multiple imputation for each treatment arm separately. A penalty of 0.4% is added to the week 26 values for all premature treatment discontinued subjects, and subject with missing HbA1c values at week 26 in the IDegAsp arm. Each of the imputed data sets are analysed through an analysis of covariance (ANCOVA).
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of IDegAsp OD versus IGlar OD + IAsp OD was considered confirmed if the 95% confidence interval for the mean treatment difference was entirely below 0.40%.
Statistical Test of Hypothesis p-Value <0.0001
Comments One-sided p-value for test of non-inferiority.
Method ANCOVA
Comments Treatment, region, sex, previous insulin treatment and previous OAD treatment as categorical fixed effects and baseline response and age as covariate.
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.06 to 0.21
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Change in HbA1c (%) - Week 38
Description Change from baseline (week 0) in HbA1c was evaluated 38 weeks after randomisation.
Time Frame Week 0, week 38

Outcome Measure Data

Analysis Population Description
FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 267 265
Baseline (week 0)
8.2
(0.8)
8.1
(0.7)
Change from baseline (week 38)
-1.2
(0.9)
-1.2
(0.9)
3. Secondary Outcome
Title Responder (Yes/No) for HbA1c < 7%
Description Participants achieving (yes/no) HbA1c <7% was evaluated 26 and 38 weeks after randomisation, respectively.
Time Frame Week 26 and week 38

Outcome Measure Data

Analysis Population Description
FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 267 265
Week 26: Yes
120
44.9%
120
45.3%
Week 26: No
121
45.3%
122
46%
Week 38: Yes
139
52.1%
140
52.8%
Week 38: No
95
35.6%
93
35.1%
4. Secondary Outcome
Title Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia
Description Participants achieving (yes/no) HbA1c <7% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia, was evaluated 26 and 38 weeks after randomisation, respectively. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Time Frame Week 26 and week 38

Outcome Measure Data

Analysis Population Description
FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 267 265
Week 26: Yes
73
27.3%
61
23%
Week 26: No
168
62.9%
181
68.3%
Week 38: Yes
60
22.5%
56
21.1%
Week 38: No
174
65.2%
177
66.8%
5. Secondary Outcome
Title Change in FPG
Description Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated 26 and 38 weeks after randomisation, respectively.
Time Frame Week 0, week 26, week 38

Outcome Measure Data

Analysis Population Description
FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 267 265
Baseline: Week 0
162.4
(47.8)
157.8
(47.8)
Change from baseline: Week 26
-42.1
(52.1)
-40.6
(59.2)
Change from baseline: Week 38
-48.6
(54.2)
-41.5
(55.3)
6. Secondary Outcome
Title Change in Pre-breakfast SMPG (Used for Titration)
Description Reported results are observed pre-breakfast self-measured plasma glucose (SMPG; used for titration) values at week 1 (baseline) and 26 and 38 weeks after randomisation.
Time Frame Week 1, week 26, week 38

Outcome Measure Data

Analysis Population Description
FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 267 265
Week 1 (Baseline)
158.3
(45.7)
149.4
(43.8)
Week 26
107.5
(24.8)
103.4
(20.7)
Week 38
102.9
(20.0)
103.8
(22.5)
7. Secondary Outcome
Title Change in Postprandial SMPG Increment (From 9-point Profile)
Description Change from baseline (week 0) in postprandial SMPG increment (from 9-point profile) was evaluated 26 and 38 weeks after randomisation, respectively. 9-point SMPG profiles were measured starting in the morning 2 days prior to the scheduled visit at the time points described below: 1) Before breakfast (2 days prior to visit) 2) 90 minutes after start of the breakfast 3) Before lunch 4) 90 minutes after start of the lunch 5) Before dinner/main evening meal 6) 90 minutes after start of the dinner/main evening meal 7) At bedtime (2 days or 1 day prior to visit depending on actual clock time) 8) At 4 a.m. (1 day prior to visit) 9) Before breakfast at the following day (1 day prior to the visit).
Time Frame Week 0, week 26, week 38

Outcome Measure Data

Analysis Population Description
FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 267 265
Baseline: Week 0
54.5
(37.7)
48.4
(38.0)
Change from baseline: Week 26
-10.8
(46.3)
-8.7
(40.6)
Change from baseline: Week 38
-17.7
(40.0)
-19.7
(45.0)
8. Secondary Outcome
Title Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Description Number of nocturnal, treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.
Time Frame Weeks 0-26, weeks 16-26, weeks 0-38

Outcome Measure Data

Analysis Population Description
Safety analysis set, which included all subjects receiving at least one dose of the investigational product (IDegAsp) or comparator (IGlar). Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 265 263
Weeks 0-26
61
118
Weeks 16-26
24
58
Weeks 0-38
113
189
9. Secondary Outcome
Title Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Description Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.
Time Frame Weeks 0-26, weeks 16-26, weeks 0-38

Outcome Measure Data

Analysis Population Description
Safety analysis set, which included all subjects receiving at least one dose of the investigational product or comparator. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 265 263
Weeks 0-26
329
376
Weeks 16-26
154
194
Weeks 0-38
537
640
10. Secondary Outcome
Title Total Insulin Dose
Description Total insulin dose was evaluated 26 and 38 weeks after randomisation, respectively.
Time Frame Week 26 and week 38

Outcome Measure Data

Analysis Population Description
Safety analysis set, which included all subjects receiving at least one dose of the investigational product or comparator. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 265 263
Week 26
70.9
(41.5)
79.4
(37.7)
Week 38
83.4
(51.3)
89.3
(43.1)
11. Secondary Outcome
Title Change in Body Weight
Description Change from baseline (week 0) in body weight was evaluated 26 and 38 weeks after randomisation, respectively.
Time Frame Week 0, week 26, week 38

Outcome Measure Data

Analysis Population Description
Safety analysis set, which included all subjects receiving at least one dose of the investigational product or comparator. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 265 263
Baseline: Week 0
88.5
(18.6)
88.4
(17.5)
Change from basline: Week 26
1.7
(3.2)
1.4
(3.2)
Change from basline: Week 38
2.5
(3.8)
2.4
(3.2)
12. Secondary Outcome
Title Incidence of TEAEs
Description Number of treatment emergent adverse events (TEAEs) were analysed during the following periods: weeks 0-26, weeks 26-38 and weeks 0-38. Treatment emergent: An adverse event that had an onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. If an event had an onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period, or if it had an onset date within 7 days after the last drug date, then this event was also to be considered as a TEAE.
Time Frame Weeks 0-26, weeks 26-38, weeks 0-38

Outcome Measure Data

Analysis Population Description
Safety analysis set, which included all subjects receiving at least one dose of the investigational product (IDegAsp) or comparator (IGlar). Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
Measure Participants 265 263
Weeks 0-26
441
408
Weeks 26-38
173
117
Weeks 0-38
614
525

Adverse Events

Time Frame Week 0 to week 38 (treatment period) + 7 days (follow-up period).
Adverse Event Reporting Description All presented adverse events are treatment emergent (i.e., TEAEs). Results are based on the safety analysis set, which included all subjects receiving at least one dose of the investigational product.
Arm/Group Title Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Arm/Group Description Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): IDegAsp OD administered at the largest meal each day with or without OAD(s). Subjects switching from pre-trial basal insulin OD or more to IDegAsp OD at trial entry were to transfer unit-to-unit. 2) Intensification period (period-2, week 26-38): IDegAsp OD/BID administered at the largest meal(s) each day (in the case of BID dosing, one meal being dinner) based on individual needs with or without OAD(s). Subjects received treatment for 38 weeks as per the following sequence: 1) Initiation period (period-1, week 0-26): Insulin glargine (IGlar) OD administered in accordance with local labelling and insulin aspart (IAsp) OD administered at the largest meal with or without OAD(s). Subjects switching from pre-trial basal insulin OD to IGlar OD were also to transfer unit-to-unit to IGlar, while subjects switching from basal insulin more than OD to IGlar OD were to reduce the initial total daily dose by 20% or according to local labelling. IAsp was to be initiated at 4 units with the largest meal. 2) Intensification period (period-2, week 26-38): IGlar OD administered in accordance with local labelling and IAsp 1-3 times daily administered at main meals based on individual needs with or without OAD(s).
All Cause Mortality
Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/265 (0%) 2/263 (0.8%)
Serious Adverse Events
Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 18/265 (6.8%) 20/263 (7.6%)
Cardiac disorders
Acute myocardial infarction 1/265 (0.4%) 1 1/263 (0.4%) 1
Coronary artery disease 2/265 (0.8%) 2 1/263 (0.4%) 1
Mitral valve incompetence 1/265 (0.4%) 1 0/263 (0%) 0
Myocardial ischaemia 1/265 (0.4%) 1 1/263 (0.4%) 1
Ear and labyrinth disorders
Vertigo 0/265 (0%) 0 2/263 (0.8%) 2
Endocrine disorders
Adrenal mass 0/265 (0%) 0 1/263 (0.4%) 1
Gastrointestinal disorders
Colitis 0/265 (0%) 0 1/263 (0.4%) 1
Gastric polyps 0/265 (0%) 0 1/263 (0.4%) 1
Pancreatitis 1/265 (0.4%) 1 0/263 (0%) 0
General disorders
Non-cardiac chest pain 0/265 (0%) 0 1/263 (0.4%) 1
Hepatobiliary disorders
Cholelithiasis 0/265 (0%) 0 1/263 (0.4%) 1
Hepatic cirrhosis 0/265 (0%) 0 1/263 (0.4%) 1
Infections and infestations
Appendicitis 1/265 (0.4%) 1 0/263 (0%) 0
Bronchitis 0/265 (0%) 0 1/263 (0.4%) 1
Epiglottitis 1/265 (0.4%) 1 0/263 (0%) 0
Furuncle 1/265 (0.4%) 1 0/263 (0%) 0
Infected skin ulcer 1/265 (0.4%) 1 0/263 (0%) 0
Meningitis viral 0/265 (0%) 0 1/263 (0.4%) 1
Peritonitis 1/265 (0.4%) 1 0/263 (0%) 0
Peritonsillar abscess 1/265 (0.4%) 1 0/263 (0%) 0
Pneumonia 1/265 (0.4%) 1 1/263 (0.4%) 1
Respiratory tract infection viral 1/265 (0.4%) 1 0/263 (0%) 0
Injury, poisoning and procedural complications
Accidental overdose 0/265 (0%) 0 1/263 (0.4%) 1
Fall 0/265 (0%) 0 1/263 (0.4%) 1
Femoral neck fracture 1/265 (0.4%) 1 0/263 (0%) 0
Humerus fracture 0/265 (0%) 0 1/263 (0.4%) 1
Metabolism and nutrition disorders
Hypoglycaemia 1/265 (0.4%) 1 0/263 (0%) 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion 1/265 (0.4%) 1 0/263 (0%) 0
Spinal osteoarthritis 1/265 (0.4%) 1 0/263 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon 0/265 (0%) 0 1/263 (0.4%) 1
Basal cell carcinoma 1/265 (0.4%) 1 0/263 (0%) 0
Malignant melanoma 1/265 (0.4%) 1 0/263 (0%) 0
Malignant melanoma in situ 1/265 (0.4%) 1 0/263 (0%) 0
Pancreatic carcinoma metastatic 0/265 (0%) 0 2/263 (0.8%) 2
Pituitary tumour benign 1/265 (0.4%) 1 0/263 (0%) 0
Nervous system disorders
Facial paralysis 1/265 (0.4%) 1 0/263 (0%) 0
VIth nerve paralysis 0/265 (0%) 0 1/263 (0.4%) 1
Renal and urinary disorders
Tubulointerstitial nephritis 1/265 (0.4%) 1 0/263 (0%) 0
Ureterolithiasis 0/265 (0%) 0 1/263 (0.4%) 1
Respiratory, thoracic and mediastinal disorders
Asthma 0/265 (0%) 0 1/263 (0.4%) 1
Skin and subcutaneous tissue disorders
Hidradenitis 0/265 (0%) 0 1/263 (0.4%) 1
Surgical and medical procedures
Cholecystectomy 0/265 (0%) 0 1/263 (0.4%) 1
Hernia repair 0/265 (0%) 0 1/263 (0.4%) 1
Other (Not Including Serious) Adverse Events
Insulin Degludec/Insulin Aspart Insulin Glargine + Insulin Aspart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 74/265 (27.9%) 57/263 (21.7%)
Infections and infestations
Nasopharyngitis 36/265 (13.6%) 49 22/263 (8.4%) 27
Upper respiratory tract infection 15/265 (5.7%) 17 17/263 (6.5%) 17
Musculoskeletal and connective tissue disorders
Back pain 16/265 (6%) 17 9/263 (3.4%) 9
Nervous system disorders
Headache 27/265 (10.2%) 52 16/263 (6.1%) 23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.

Results Point of Contact

Name/Title Clinical Reporting Anchor and Disclosure (1452)
Organization Novo Nordisk A/S
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02906917
Other Study ID Numbers:
  • NN5401-4266
  • 2015-004768-12
  • U1111-1175-7895
First Posted:
Sep 20, 2016
Last Update Posted:
Nov 13, 2019
Last Verified:
Nov 1, 2019