BEGIN™: Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01364428
• Collaborator: (none)
• Enrollment: 373
• Locations: 45
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 8.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 373 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial Comparing the Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Subjects With Type 2 Diabetes Mellitus (BEGIN™: COMPARE)
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg 200 U/mL	Drug: insulin degludec; Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment. Dose was individually adjusted.
Experimental: IDeg 100 U/mL	Drug: insulin degludec; Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment. Dose was individually adjusted.

Outcome Measures

Primary Outcome Measures

1. Change in Glycosylated Haemoglobin (HbA1c) [Week 0, Week 22]

   Change from baseline in HbA1c after 22 weeks of treatment

Secondary Outcome Measures

1. Change in Fasting Plasma Glucose (FPG) [Week 0, Week 22]

   Change from baseline in FPG after 22 weeks of treatment.

2. Rate of Treatment Emergent Adverse Events (AEs) [Week 0 to Week 22 + 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 22 + 7 days follow up]

   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 22 + 7 days follow up]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)

• Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)

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

• Body mass index (BMI) below or equal to 45 kg/m^2

• Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

Exclusion Criteria:

• Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)

• Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)

• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)

• Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period

• Known or suspected hypersensitivity to trial products or related products

• The receipt of any investigational drug within 4 weeks prior to randomisation (visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Huntsville	Alabama	United States	35801
2	Novo Nordisk Investigational Site	Goodyear	Arizona	United States	85395
3	Novo Nordisk Investigational Site	Mesa	Arizona	United States	85213
4	Novo Nordisk Investigational Site	Phoenix	Arizona	United States	85018
5	Novo Nordisk Investigational Site	Concord	California	United States	94520
6	Novo Nordisk Investigational Site	Greenbrae	California	United States	94904
7	Novo Nordisk Investigational Site	Montclair	California	United States	91763
8	Novo Nordisk Investigational Site	National City	California	United States	91950
9	Novo Nordisk Investigational Site	Palm Springs	California	United States	92262
10	Novo Nordisk Investigational Site	Bradenton	Florida	United States	34201
11	Novo Nordisk Investigational Site	Clearwater	Florida	United States	33765
12	Novo Nordisk Investigational Site	Kissimmee	Florida	United States	34741
13	Novo Nordisk Investigational Site	Miami	Florida	United States	33135
14	Novo Nordisk Investigational Site	Tampa	Florida	United States	33603
15	Novo Nordisk Investigational Site	West Palm Beach	Florida	United States	33401
16	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30318
17	Novo Nordisk Investigational Site	Springfield	Illinois	United States	62711
18	Novo Nordisk Investigational Site	Evansville	Indiana	United States	47714
19	Novo Nordisk Investigational Site	Metairie	Louisiana	United States	70002
20	Novo Nordisk Investigational Site	Slidell	Louisiana	United States	70461-4231
21	Novo Nordisk Investigational Site	Rockville	Maryland	United States	20852
22	Novo Nordisk Investigational Site	Waltham	Massachusetts	United States	02453-2717
23	Novo Nordisk Investigational Site	Detroit	Michigan	United States	48235
24	Novo Nordisk Investigational Site	Jefferson City	Missouri	United States	65109
25	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68114
26	Novo Nordisk Investigational Site	Lawrenceville	New Jersey	United States	08648
27	Novo Nordisk Investigational Site	Toms River	New Jersey	United States	08755-8050
28	Novo Nordisk Investigational Site	Staten Island	New York	United States	10301
29	Novo Nordisk Investigational Site	West Seneca	New York	United States	14224
30	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
31	Novo Nordisk Investigational Site	Greenville	North Carolina	United States	27834
32	Novo Nordisk Investigational Site	Canton	Ohio	United States	44718
33	Novo Nordisk Investigational Site	Franklin	Ohio	United States	45005
34	Novo Nordisk Investigational Site	Melrose Park	Pennsylvania	United States	19027
35	Novo Nordisk Investigational Site	Brentwood	Tennessee	United States	37027
36	Novo Nordisk Investigational Site	Chattanooga	Tennessee	United States	37404
37	Novo Nordisk Investigational Site	Chattanooga	Tennessee	United States	37411
38	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
39	Novo Nordisk Investigational Site	Dallas	Texas	United States	75246
40	Novo Nordisk Investigational Site	Hurst	Texas	United States	76054
41	Novo Nordisk Investigational Site	Irving	Texas	United States	75061-2210
42	Novo Nordisk Investigational Site	Round Rock	Texas	United States	78681
43	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78224
44	Novo Nordisk Investigational Site	Olympia	Washington	United States	98502
45	Novo Nordisk Investigational Site	Renton	Washington	United States	98057

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: NCT01364428
• Other Study ID Numbers: NN1250-3923; U1111-1119-2518
• First Posted: Jun 2, 2011
• Last Update Posted: Mar 6, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 44 sites within United States of America.
Pre-assignment Detail	Subjects who were treated with basal insulin in combination with unchanged dosing of oral antidiabetic drug treatment (e.g. metformin, pioglitazone or DPP-IV inhibitor) in any approved dose or combination at unchanged dosing for at least 12 weeks prior to randomisation in a 1:1 manner to IDeg 200 U/mL or IDeg.

Arm/Group Title	IDeg 200 U/mL	IDeg
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.	Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
Period Title: Overall Study
STARTED	186	187
Exposed	184	187
COMPLETED	166	172
NOT COMPLETED	20	15

Baseline Characteristics

Arm/Group Title	IDeg 200 U/mL	IDeg	Total
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.	Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.	Total of all reporting groups
Overall Participants	186	187	373
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (10.0)	60.3 (10.2)	59.8 (10.1)
Sex: Female, Male (Count of Participants)
Female	98 52.7%	70 37.4%	168 45%
Male	88 47.3%	117 62.6%	205 55%
Glycosylated haemoglobin (HbA1c) (percentage of glycosylated haemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]	8.1 (0.9)	8.2 (0.9)	8.2 (0.9)
Fasting plasma glucose (FPG) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	8.3 (3.0)	8.3 (3.4)	8.3 (3.2)

Outcome Measures

1. Primary Outcome

Title	Change in Glycosylated Haemoglobin (HbA1c)
Description	Change from baseline in HbA1c after 22 weeks of treatment
Time Frame	Week 0, Week 22

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IDeg 200 U/mL	IDeg
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.	Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
Measure Participants	186	187
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]	-0.79 (0.89)	-0.70 (0.90)

2. Secondary Outcome

Title	Change in Fasting Plasma Glucose (FPG)
Description	Change from baseline in FPG after 22 weeks of treatment.
Time Frame	Week 0, Week 22

Outcome Measure Data

Analysis Population Description

The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 5 subjects baseline values were missing.

Arm/Group Title	IDeg 200 U/mL	IDeg
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.	Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
Measure Participants	182	186
Mean (Standard Deviation) [mmol/L]	-2.26 (3.07)	-2.40 (3.42)

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 22 + 7 days follow up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IDeg 200 U/mL	IDeg
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.	Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
Measure Participants	184	187
Adverse events (AEs)	416	300
Serious AEs	20	16
Severe AEs	27	21
Moderate AEs	130	107
Mild AEs	259	172
Fatal AEs	0	0

4. Secondary Outcome

Title	Rate of Confirmed Hypoglycaemic Episodes
Description	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 22 + 7 days follow up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IDeg 200 U/mL	IDeg
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.	Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
Measure Participants	184	187
Number [Episodes/100 years of patient exposure]	517	566

5. Secondary Outcome

Title	Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Description	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 22 + 7 days follow up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	IDeg 200 U/mL	IDeg
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.	Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
Measure Participants	184	187
Number [Episodes/100 years of patient exposure]	127	170

Adverse Events

Time Frame	The adverse events were collected in a time frame of 22 weeks + 7 days follow up.
Adverse Event Reporting Description	The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Arm/Group Title	IDeg 200 U/mL		IDeg
Arm/Group Description	Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.		Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
All Cause Mortality
	IDeg 200 U/mL		IDeg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IDeg 200 U/mL		IDeg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/184 (4.9%)		11/187 (5.9%)
Cardiac disorders
Coronary artery disease	2/184 (1.1%)	2	0/187 (0%)	0
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic	1/184 (0.5%)	1	0/187 (0%)	0
Pancreatitis	1/184 (0.5%)	1	1/187 (0.5%)	1
General disorders
Chest pain	1/184 (0.5%)	1	0/187 (0%)	0
Hepatobiliary disorders
Cholecystitis	1/184 (0.5%)	1	0/187 (0%)	0
Cholelithiasis	1/184 (0.5%)	1	1/187 (0.5%)	1
Infections and infestations
Diverticulitis	0/184 (0%)	0	1/187 (0.5%)	1
Osteomyelitis	1/184 (0.5%)	1	0/187 (0%)	0
Viral infection	1/184 (0.5%)	1	0/187 (0%)	0
Injury, poisoning and procedural complications
Heat stroke	0/184 (0%)	0	1/187 (0.5%)	1
Hip fracture	1/184 (0.5%)	1	0/187 (0%)	0
Metabolism and nutrition disorders
Hypoglycaemia	0/184 (0%)	0	1/187 (0.5%)	1
Hyponatraemia	1/184 (0.5%)	1	1/187 (0.5%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/184 (0.5%)	1	0/187 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer	0/184 (0%)	0	1/187 (0.5%)	1
Prostate cancer	0/184 (0%)	0	1/187 (0.5%)	1
Tongue neoplasm malignant	0/184 (0%)	0	1/187 (0.5%)	1
Psychiatric disorders
Alcohol abuse	1/184 (0.5%)	1	0/187 (0%)	0
Anxiety	0/184 (0%)	0	1/187 (0.5%)	1
Drug abuse	1/184 (0.5%)	1	0/187 (0%)	0
Suicidal ideation	0/184 (0%)	0	2/187 (1.1%)	2
Respiratory, thoracic and mediastinal disorders
Cough	1/184 (0.5%)	1	0/187 (0%)	0
Other (Not Including Serious) Adverse Events
	IDeg 200 U/mL		IDeg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/184 (24.5%)		26/187 (13.9%)
Gastrointestinal disorders
Diarrhoea	17/184 (9.2%)	20	4/187 (2.1%)	4
Infections and infestations
Nasopharyngitis	18/184 (9.8%)	19	12/187 (6.4%)	14
Upper respiratory tract infection	15/184 (8.2%)	17	10/187 (5.3%)	10

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.