DUAL™ II: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01392573
• Collaborator: (none)
• Enrollment: 413
• Locations: 86
• Arms: 2
• Actual Duration (Months): 10.2
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 413 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes
• Actual Study Start Date: Nov 28, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 4, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDegLira + metformin IDegLira was injected subcutaneously once daily for 26 weeks.	Drug: insulin degludec/liraglutide; IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.
Experimental: IDeg + metformin IDeg was injected subcutaneously once daily for 26 weeks.	Drug: insulin degludec; IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.

Outcome Measures

Primary Outcome Measures

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

   Observed mean change from baseline in HbA1c after 26 Weeks of treatment.

Secondary Outcome Measures

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

   Observed mean change from baseline in body weight after 26 Weeks of treatment.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects with type 2 diabetes

• HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)

• Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)

• BMI (Body Mass Index) more than or equal to 27 kg/m^2

Exclusion Criteria:

• Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start

• Impaired liver function

• Impaired renal function

• Screening calcitonin equal to or above 50 ng/l

• Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)

• Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures

• Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)

• Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion

• History of chronic pancreatitis or idiopathic acute pancreatitis

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	Vestavia Hills	Alabama	United States	35209
3	Novo Nordisk Investigational Site	Anaheim	California	United States	92801
4	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
5	Novo Nordisk Investigational Site	Tustin	California	United States	92780
6	Novo Nordisk Investigational Site	Ventura	California	United States	93003
7	Novo Nordisk Investigational Site	Colorado Springs	Colorado	United States	80910
8	Novo Nordisk Investigational Site	Waterbury	Connecticut	United States	06708
9	Novo Nordisk Investigational Site	Melbourne	Florida	United States	32934
10	Novo Nordisk Investigational Site	Miami	Florida	United States	33156
11	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
12	Novo Nordisk Investigational Site	Arlington Heights	Illinois	United States	60004-2315
13	Novo Nordisk Investigational Site	Avon	Illinois	United States	46123
14	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60607
15	Novo Nordisk Investigational Site	Crystal Lake	Illinois	United States	60012
16	Novo Nordisk Investigational Site	Gurnee	Illinois	United States	60031
17	Novo Nordisk Investigational Site	Greenfield	Indiana	United States	46140
18	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46254
19	Novo Nordisk Investigational Site	Muncie	Indiana	United States	47304
20	Novo Nordisk Investigational Site	New Albany	Indiana	United States	47150
21	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
22	Novo Nordisk Investigational Site	Metairie	Louisiana	United States	70002
23	Novo Nordisk Investigational Site	Metairie	Louisiana	United States	70006-2930
24	Novo Nordisk Investigational Site	Slidell	Louisiana	United States	70461-4231
25	Novo Nordisk Investigational Site	Rockville	Maryland	United States	20852
26	Novo Nordisk Investigational Site	Methuen	Massachusetts	United States	01844
27	Novo Nordisk Investigational Site	North Dartmouth	Massachusetts	United States	02747
28	Novo Nordisk Investigational Site	Waltham	Massachusetts	United States	02453
29	Novo Nordisk Investigational Site	Southfield	Michigan	United States	48034-7661
30	Novo Nordisk Investigational Site	Chesterfield	Missouri	United States	63017
31	Novo Nordisk Investigational Site	Saint Charles	Missouri	United States	63303
32	Novo Nordisk Investigational Site	Nashua	New Hampshire	United States	03063
33	Novo Nordisk Investigational Site	Lawrenceville	New Jersey	United States	08648
34	Novo Nordisk Investigational Site	Toms River	New Jersey	United States	08755-8050
35	Novo Nordisk Investigational Site	Albany	New York	United States	12206
36	Novo Nordisk Investigational Site	Smithtown	New York	United States	11787
37	Novo Nordisk Investigational Site	Asheboro	North Carolina	United States	27203
38	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27517
39	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
40	Novo Nordisk Investigational Site	Hickory	North Carolina	United States	28602
41	Novo Nordisk Investigational Site	Statesville	North Carolina	United States	28625
42	Novo Nordisk Investigational Site	Beaver	Pennsylvania	United States	15009
43	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19107
44	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19152
45	Novo Nordisk Investigational Site	Greer	South Carolina	United States	29651
46	Novo Nordisk Investigational Site	Simpsonville	South Carolina	United States	29681
47	Novo Nordisk Investigational Site	Nashville	Tennessee	United States	37203
48	Novo Nordisk Investigational Site	Arlington	Texas	United States	76014
49	Novo Nordisk Investigational Site	Austin	Texas	United States	78731
50	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
51	Novo Nordisk Investigational Site	Dallas	Texas	United States	75246
52	Novo Nordisk Investigational Site	Dallas	Texas	United States	75251
53	Novo Nordisk Investigational Site	Hurst	Texas	United States	76054
54	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78215
55	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78224
56	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229
57	Novo Nordisk Investigational Site	Sugar Land	Texas	United States	77478
58	Novo Nordisk Investigational Site	Salt Lake City	Utah	United States	84107
59	Novo Nordisk Investigational Site	Burgas		Bulgaria	8000
60	Novo Nordisk Investigational Site	Haskovo		Bulgaria	6300
61	Novo Nordisk Investigational Site	Lukovit		Bulgaria	5770
62	Novo Nordisk Investigational Site	Plovdiv		Bulgaria	4001
63	Novo Nordisk Investigational Site	Ruse		Bulgaria	7000
64	Novo Nordisk Investigational Site	Sofia		Bulgaria	1712
65	Novo Nordisk Investigational Site	Gentofte		Denmark	2820
66	Novo Nordisk Investigational Site	Hellerup		Denmark	2900
67	Novo Nordisk Investigational Site	Århus C		Denmark	8000
68	Novo Nordisk Investigational Site	Budapest		Hungary	1125
69	Novo Nordisk Investigational Site	Debrecen		Hungary	4043
70	Novo Nordisk Investigational Site	Eger		Hungary	H-3300
71	Novo Nordisk Investigational Site	Szombathely		Hungary	H-9700
72	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	400008
73	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	400053
74	Novo Nordisk Investigational Site	Pune	Maharashtra	India	411001.
75	Novo Nordisk Investigational Site	Chennai	Tamil Nadu	India	600086
76	Novo Nordisk Investigational Site	Kolkata	West Bengal	India	700064
77	Novo Nordisk Investigational Site	Dhantoli, Nagpur		India	440012
78	Novo Nordisk Investigational Site	Koper		Slovenia	SI-6000
79	Novo Nordisk Investigational Site	Ljubljana		Slovenia	1525
80	Novo Nordisk Investigational Site	Novo mesto		Slovenia	8000
81	Novo Nordisk Investigational Site	Basel		Switzerland	4031
82	Novo Nordisk Investigational Site	Bern		Switzerland	3010
83	Novo Nordisk Investigational Site	Interlaken-Unterseen		Switzerland	3800
84	Novo Nordisk Investigational Site	Lausanne		Switzerland	1011
85	Novo Nordisk Investigational Site	Luzern 16		Switzerland	6000
86	Novo Nordisk Investigational Site	St. Gallen		Switzerland	9007

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

• Ericsson Å, Lundqvist A. Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden. Appl Health Econ Health Policy. 2017 Apr;15(2):237-248. doi: 10.1007/s40258-016-0301-y.
• Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01392573
• Other Study ID Numbers: NN9068-3912; 2011-002336-72; U1111-1121-4897
• First Posted: Jul 12, 2011
• Last Update Posted: Jan 3, 2019
• Last Verified: Dec 1, 2018

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

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 75 sites in 7 countries: Bulgaria (6), Switzerland (2), Denmark (3), Hungary (3), India (6), Slovenia (3), and the United States (52).

Arm/Group Title	IDegLira	IDeg
Arm/Group Description	Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
Period Title: Overall Study
STARTED	207	206
Exposed	207	206
COMPLETED	175	171
NOT COMPLETED	32	35

Baseline Characteristics

Arm/Group Title	IDegLira	IDeg	Total
Arm/Group Description	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).	Total of all reporting groups
Overall Participants	199	199	398
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.8 (8.9)	57.5 (10.5)	57.2 (9.7)
Sex: Female, Male (Count of Participants)
Female	87 43.7%	93 46.7%	180 45.2%
Male	112 56.3%	106 53.3%	218 54.8%
HbA1c (glycosylated haemoglobin) (percentage of glycosylated haemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]	8.7 (0.7)	8.8 (0.7)	8.8 (0.7)
Body Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	95.4 (19.4)	93.5 (20.0)	94.5 (19.7)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Description	Observed mean 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. Missing data was imputed using last observation carried forward (LOCF).

Arm/Group Title	IDegLira	IDeg
Arm/Group Description	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
Measure Participants	199	199
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]	-1.90 (1.09)	-0.89 (1.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IDegLira, IDeg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate
Method of Estimation	Estimation Parameter	Treatment contrast
	Estimated Value	-1.05
	Confidence Interval	(2-Sided) 95%; -1.25 to -0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Full analysis set. Missing data was imputed using LOCF.

Arm/Group Title	IDegLira	IDeg
Arm/Group Description	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
Measure Participants	199	199
Mean (Standard Deviation) [kg]	-2.7 (3.7)	0.0 (3.4)

Adverse Events

Time Frame	Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Adverse Event Reporting Description	Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
Arm/Group Title	IDegLira		IDeg
Arm/Group Description	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.		Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
All Cause Mortality
	IDegLira		IDeg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IDegLira		IDeg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/199 (3.5%)		11/199 (5.5%)
Cardiac disorders
Acute myocardial infarction	1/199 (0.5%)	1	1/199 (0.5%)	1
Atrial fibrillation	1/199 (0.5%)	1	0/199 (0%)	0
Ventricular fibrillation	1/199 (0.5%)	1	0/199 (0%)	0
Ventricular tachycardia	1/199 (0.5%)	1	0/199 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	1/199 (0.5%)	1	0/199 (0%)	0
Infections and infestations
Pneumonia	1/199 (0.5%)	1	1/199 (0.5%)	1
Vestibular neuronitis	1/199 (0.5%)	1	0/199 (0%)	0
Injury, poisoning and procedural complications
Acetabulum fracture	0/199 (0%)	0	1/199 (0.5%)	1
Foot fracture	0/199 (0%)	0	1/199 (0.5%)	1
Humerus fracture	0/199 (0%)	0	1/199 (0.5%)	1
Metabolism and nutrition disorders
Hypoglycaemia	1/199 (0.5%)	1	0/199 (0%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/199 (0%)	0	1/199 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic	0/199 (0%)	0	1/199 (0.5%)	1
Nervous system disorders
Convulsion	0/199 (0%)	0	1/199 (0.5%)	1
Ischaemic stroke	0/199 (0%)	0	1/199 (0.5%)	1
Mononeuropathy	0/199 (0%)	0	1/199 (0.5%)	1
VIIth nerve paralysis	1/199 (0.5%)	1	0/199 (0%)	0
Vertigo CNS origin	0/199 (0%)	0	1/199 (0.5%)	1
Psychiatric disorders
Major depression	1/199 (0.5%)	1	0/199 (0%)	0
Renal and urinary disorders
Renal failure acute	1/199 (0.5%)	1	0/199 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/199 (0%)	0	1/199 (0.5%)	1
Surgical and medical procedures
Coronary revascularisation	0/199 (0%)	0	1/199 (0.5%)	1
Other (Not Including Serious) Adverse Events
	IDegLira		IDeg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/199 (22.6%)		29/199 (14.6%)
Gastrointestinal disorders
Diarrhoea	13/199 (6.5%)	21	7/199 (3.5%)	8
Nausea	13/199 (6.5%)	20	7/199 (3.5%)	7
Infections and infestations
Nasopharyngitis	5/199 (2.5%)	5	12/199 (6%)	14
Investigations
Lipase increased	12/199 (6%)	12	7/199 (3.5%)	7
Nervous system disorders
Headache	12/199 (6%)	23	4/199 (2%)	6

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.