BOOST™: Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01272193
• Collaborator: (none)
• Enrollment: 296
• Locations: 50
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: insulin degludec/insulin aspart; Drug: insulin glargine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 296 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDegAsp OD	Drug: insulin degludec/insulin aspart; Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).; Drug: insulin glargine; Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
Active Comparator: IGlar OD	Drug: insulin glargine; Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

Outcome Measures

Primary Outcome Measures

1. Change in Glycosylated Haemoglobin (HbA1c) [Week 0, Week 26]

   Observed change from baseline in HbA1c after 26 weeks of treatment

Secondary Outcome Measures

1. Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal [Week 26]

   Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal

2. Rate of Treatment Emergent Adverse Events (AEs) [Week 0 to Week 26 + 7 days follow up]

   Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

3. Rate of Confirmed Hypoglycaemic Episodes [Week 0 to Week 26 + 7 days follow up]

   Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

4. Rate of Nocturnal Confirmed Hypoglycaemic Episodes [Week 0 to Week 26 + 7 days follow up]

   Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.

5. Change in Body Weight [Week 0, Week 26]

   Observed change from baseline in body weight after 26 weeks of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

• HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis

• Body Mass Index (BMI) below or equal to 35.0 kg/m^2

• Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Exclusion Criteria:

• Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors

• Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation

• Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Asahikawa-shi, Hokkaido		Japan	070 0002
2	Novo Nordisk Investigational Site	Chigasaki-shi, Kanagawa		Japan	253 0052
3	Novo Nordisk Investigational Site	Chuo-ku, Tokyo		Japan	103 0002
4	Novo Nordisk Investigational Site	Chuo-ku, Tokyo		Japan	103 0027
5	Novo Nordisk Investigational Site	Ebina-shi		Japan	243 0432
6	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka		Japan	815 8555
7	Novo Nordisk Investigational Site	Iruma-shi, Saitama		Japan	358 0003
8	Novo Nordisk Investigational Site	Izumisano-shi		Japan	598 0048
9	Novo Nordisk Investigational Site	Kamakura-shi		Japan	247 0056
10	Novo Nordisk Investigational Site	Kanagawa-shi, Yokohama		Japan	221 0802
11	Novo Nordisk Investigational Site	Kashiwa-shi, Chiba		Japan	277 0825
12	Novo Nordisk Investigational Site	Kashiwara-shi, Osaka		Japan	582 0005
13	Novo Nordisk Investigational Site	Katsushika-ku, Tokyo		Japan	125 0054
14	Novo Nordisk Investigational Site	Kawagoe-shi, Saitama		Japan	350 0851
15	Novo Nordisk Investigational Site	Kitakyushu-shi, Fukuoka		Japan	800 0252
16	Novo Nordisk Investigational Site	Koriyama-shi, Fukushima		Japan	963 8851
17	Novo Nordisk Investigational Site	Kumamoto-shi, Kumamoto		Japan	861 8045
18	Novo Nordisk Investigational Site	Kumamoto-shi,Kumamoto		Japan	862 0976
19	Novo Nordisk Investigational Site	Kurume-shi, Fukuoka		Japan	830 8577
20	Novo Nordisk Investigational Site	Kurume-shi, Fukuoka		Japan	839 0863
21	Novo Nordisk Investigational Site	Kyoto-shi, Kyoto		Japan	615 8125
22	Novo Nordisk Investigational Site	Matsumoto-shi, Nagano		Japan	399 0006
23	Novo Nordisk Investigational Site	Miyazaki-shi		Japan	880 0034
24	Novo Nordisk Investigational Site	Naha-shi,		Japan	900 0032
25	Novo Nordisk Investigational Site	Naka-shi, Ibaraki		Japan	311 0113
26	Novo Nordisk Investigational Site	Nishinomiya-shi, Hygo		Japan	662 0971
27	Novo Nordisk Investigational Site	Obihiro-shi, Hokkaido		Japan	080 0016
28	Novo Nordisk Investigational Site	Obihiro-shi, Hokkaido		Japan	080 0848
29	Novo Nordisk Investigational Site	Ogawa-machi		Japan	355 0321
30	Novo Nordisk Investigational Site	Oita-shi		Japan	870 0039
31	Novo Nordisk Investigational Site	Okawa-shi, Fukuoka		Japan	831 0016
32	Novo Nordisk Investigational Site	Ota-ku, Tokyo		Japan	144 0035
33	Novo Nordisk Investigational Site	Oyama-shi, Tochigi		Japan	323 0022
34	Novo Nordisk Investigational Site	Sapporo, Hokkaido		Japan	060 0033
35	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido		Japan	060 0062
36	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido		Japan	060-0001
37	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido		Japan	062 0007
38	Novo Nordisk Investigational Site	Sappro-shi, Hokkaido		Japan	060 8648
39	Novo Nordisk Investigational Site	Sasebo-shi, Nagasaki		Japan	857 1165
40	Novo Nordisk Investigational Site	Sendai-shi		Japan	980 0021
41	Novo Nordisk Investigational Site	Shimotsuke-shi, Tochigi		Japan	329 0433
42	Novo Nordisk Investigational Site	Shizuoka-shi		Japan	424 0853
43	Novo Nordisk Investigational Site	Tagajo-shi		Japan	985 0852
44	Novo Nordisk Investigational Site	Tagawa-shi, Fukuoka		Japan	825 8567
45	Novo Nordisk Investigational Site	Takatsuki-shi, Osaka		Japan	569 1096
46	Novo Nordisk Investigational Site	Tamana-shi, Kumamoto		Japan	865 0064
47	Novo Nordisk Investigational Site	Tokyo		Japan	167 0043
48	Novo Nordisk Investigational Site	Tsuchiura-shi, Ibaraki		Japan	300 0832
49	Novo Nordisk Investigational Site	Urasoe-shi,		Japan	901 2104
50	Novo Nordisk Investigational Site	Yokohama-shi, Kanagawa		Japan	227 0054

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01272193
• Other Study ID Numbers: NN5401-3896; U1111-1118-0124; JapicCTI-111385
• First Posted: Jan 7, 2011
• Last Update Posted: Mar 17, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 48 sites in Japan.
Pre-assignment Detail	Subjects continued on not more than 2 oral antidiabetic drugs (excluding sulphonylureas/dipeptyl peptidase-4 [DPP-4] inhibitors/glinides) at the pre-randomisation dose level and dosing frequency.

Arm/Group Title	IDegAsp OD	IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Period Title: Overall Study
STARTED	147	149
COMPLETED	137	137
NOT COMPLETED	10	12

Baseline Characteristics

Arm/Group Title	IDegAsp OD	IGlar OD	Total
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.	Total of all reporting groups
Overall Participants	147	149	296
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.0 (10.0)	61.0 (9.6)	60.5 (9.8)
Sex: Female, Male (Count of Participants)
Female	57 38.8%	50 33.6%	107 36.1%
Male	90 61.2%	99 66.4%	189 63.9%
Glycosylated haemoglobin (HbA1c) (percentage of glycosylated haemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]	8.3 (0.8)	8.5 (0.8)	8.4 (0.8)
Fasting plasma glucose (FPG) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	9.0 (1.6)	9.1 (1.9)	9.0 (1.7)
Body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	66.2 (13.4)	66.4 (13.3)	66.3 (13.4)

Outcome Measures

1. Primary Outcome

Title	Change in Glycosylated Haemoglobin (HbA1c)
Description	Observed change from baseline in HbA1c after 26 weeks of treatment
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).

Arm/Group Title	IDegAsp OD	IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Measure Participants	147	149
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]	-1.35 (0.86)	-1.22 (0.98)

2. Secondary Outcome

Title	Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Description	Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).

Arm/Group Title	IDegAsp OD	IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Measure Participants	147	149
Mean (Standard Deviation) [mmol/L]	1.4 (4.2)	4.7 (3.6)

3. Secondary Outcome

Title	Rate of Treatment Emergent Adverse Events (AEs)
Description	Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time Frame	Week 0 to Week 26 + 7 days follow up

Outcome Measure Data

Analysis Population Description

Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.

Arm/Group Title	IDegAsp OD	IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Measure Participants	147	149
Adverse events (AEs)	334	368
Serious AEs	7	4
Severe AEs	1	0
Moderate AEs	17	14
Mild AEs	316	353
Fatal AEs	0	0

4. Secondary Outcome

Title	Rate of Confirmed Hypoglycaemic Episodes
Description	Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame	Week 0 to Week 26 + 7 days follow up

Outcome Measure Data

Analysis Population Description

Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.

Arm/Group Title	IDegAsp OD	IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Measure Participants	147	149
Number [Episodes/100 years of patient exposure]	191	271

5. Secondary Outcome

Title	Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Description	Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Time Frame	Week 0 to Week 26 + 7 days follow up

Outcome Measure Data

Analysis Population Description

Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Arm/Group Title	IDegAsp OD	IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Measure Participants	147	149
Number [Episodes/100 years of patient exposure]	39	53

6. Secondary Outcome

Title	Change in Body Weight
Description	Observed change from baseline in body weight after 26 weeks of treatment
Time Frame	Week 0, Week 26

Outcome Measure Data

Analysis Population Description

Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).

Arm/Group Title	IDegAsp OD	IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Measure Participants	147	149
Mean (Standard Deviation) [kg]	0.7 (2.8)	0.7 (2.2)

Adverse Events

Time Frame	The adverse events were collected in a time frame of 26 weeks + 7 days follow up.
Adverse Event Reporting Description	Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
Arm/Group Title	IDegAsp OD		IGlar OD
Arm/Group Description	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.		Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
All Cause Mortality
	IDegAsp OD		IGlar OD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IDegAsp OD		IGlar OD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/147 (3.4%)		3/149 (2%)
Cardiac disorders
Cardiac failure	1/147 (0.7%)	1	0/149 (0%)	0
Gastrointestinal disorders
Inguinal hernia	1/147 (0.7%)	1	0/149 (0%)	0
Infections and infestations
Pulmonary tuberculosis	1/147 (0.7%)	1	0/149 (0%)	0
Musculoskeletal and connective tissue disorders
Osteitis condensans	0/147 (0%)	0	1/149 (0.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	1/147 (0.7%)	1	0/149 (0%)	0
Nervous system disorders
Cerebral infarction	1/147 (0.7%)	1	1/149 (0.7%)	1
Dizziness	0/147 (0%)	0	1/149 (0.7%)	1
Other (Not Including Serious) Adverse Events
	IDegAsp OD		IGlar OD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/147 (25.2%)		47/149 (31.5%)
Eye disorders
Diabetic retinopathy	8/147 (5.4%)	9	10/149 (6.7%)	10
Infections and infestations
Nasopharyngitis	33/147 (22.4%)	39	38/149 (25.5%)	45

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.