Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00773279
• Collaborator: (none)
• Enrollment: 242
• Locations: 65
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess and compare the effect on blood sugar control of insulin detemir and insulin aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch®) versus a Novo Nordisk marketed insulin pen (FlexPen®) in subjects with type 1 or type 2 diabetes mellitus. Furthermore, the subject's preference of the devices will be investigated by the use of questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems	Device: FlexTouch®; Device: FlexPen®	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-centre, Randomised, Open-label, Cross-over Study to Explore Effectiveness, Safety, and Preference of a New Disposable Pen PDS290 Versus FlexPen® in Subjects With Type 1 or Type 2 Diabetes
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PDS290 --> FlexPen® Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2)	Device: FlexTouch®; All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.; Device: FlexPen®; All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.
Experimental: FlexPen® --> PDS290 Subjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2)	Device: FlexTouch®; All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.; Device: FlexPen®; All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.

Outcome Measures

Primary Outcome Measures

1. HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen® [Week 12 of each treatment sequence]

Secondary Outcome Measures

1. Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use [Week 24]

   Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)

2. Summary Score for Treatment Satisfaction [Week 24]

   Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.

3. Score for Treatment Impact Measure for Diabetes [Week 24]

   Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.

4. Clinical Technical Complaints (CTCs) [Weeks 0-24 (whole trial period)]

   A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.

5. Number of Hypoglycaemic Episodes [Weeks 0-12 (first treatment) and 12-24 (second treatment)]

   Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.

6. Number of Adverse Device Effects [From randomisation (week 0) and until 7 days after Week 24 (Visit 16)]

   Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.

7. Hypoglycaemic Episodes, Number of Events Per Subject Day [Weeks 0-12 (first treatment) and 12-24 (second treatment)]

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

• Subjects diagnosed with type 1 or type 2 diabetes. If type 2 diabetics, treatment with or without oral anti diabetic medication is allowed

• Current users of vial/syringe (pen naïve) treated with short-acting insulin (insulin aspart, glulisine or lispro) and once daily long-acting insulin (detemir or glargine) or once daily long-acting insulin (detemir or glargine) alone

• Treatment with insulin (i.e. aspart, glulisine, lispro, detemir or glargine) for at least 6 months

• Body Mass Index (BMI) less than 45.0 kg/m^2

• HbA1c less than or equal to 9.0% at screening visit based on analysis from central laboratory

• Able and willing to adhere to the trial-specific insulin regimen for the entire trial period

Exclusion Criteria:

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or inadequate contraceptive techniques during the trial period (adequate contraceptive measures are considered as intrauterine device, oral contraceptives and barrier methods)

• Previous participation in this trial (screening visit)

• Systemic drugs that may influence glycaemic control (e.g., corticosteroids)

• Known or suspected allergy to trial product(s) or related products

• Known or suspected abuse of alcohol or drug abuse

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

• Previous treatment with sitagliptin

• Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, or haematological systems

• Cardiac disease defined as: Decompensated heart failure (New York Heart class III or IV, unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on electrocardiogram (ECG) over the past 12 months

• Any other severe acute or chronic illness as judged by the Investigator

• Recurrent major hypoglycaemia (defined as severe central nervous system dysfunction associated with hypoglycaemia, requiring the assistance of another person) or hypoglycaemia unawareness (defined as a condition in which subjects no longer experience the usual warning signs of hypoglycaemia; the symptoms of hypoglycaemia may be different, less pronounced or even absent) or hospitalisation for diabetic ketoacidosis during the previous six months

• Any other conditions that the Investigator judges would interfere with trial participation or evaluation of results (i.e. planned any diagnostic or therapeutic medical intervention such as surgery)

• Participated in another clinical trial and received an investigational drug within the last 4 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Burlingame	California	United States	94010
2	Novo Nordisk Investigational Site	Concord	California	United States	94520
3	Novo Nordisk Investigational Site	Encino	California	United States	91436
4	Novo Nordisk Investigational Site	Escondido	California	United States	92025
5	Novo Nordisk Investigational Site	Fresno	California	United States	93720
6	Novo Nordisk Investigational Site	Mission Viejo	California	United States	92691
7	Novo Nordisk Investigational Site	Orange	California	United States	92869
8	Novo Nordisk Investigational Site	Poway	California	United States	92064
9	Novo Nordisk Investigational Site	Salinas	California	United States	93901
10	Novo Nordisk Investigational Site	Santa Monica	California	United States	90404
11	Novo Nordisk Investigational Site	Tustin	California	United States	92780
12	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
13	Novo Nordisk Investigational Site	Aurora	Colorado	United States	80045
14	Novo Nordisk Investigational Site	Colorado Springs	Colorado	United States	80909
15	Novo Nordisk Investigational Site	Golden	Colorado	United States	80401
16	Novo Nordisk Investigational Site	Boca Raton	Florida	United States	33433
17	Novo Nordisk Investigational Site	Hollywood	Florida	United States	33021
18	Novo Nordisk Investigational Site	Maitland	Florida	United States	32751
19	Novo Nordisk Investigational Site	Miami	Florida	United States	33143
20	Novo Nordisk Investigational Site	Miami	Florida	United States	33156
21	Novo Nordisk Investigational Site	Ocala	Florida	United States	34471
22	Novo Nordisk Investigational Site	Tallahassee	Florida	United States	32308
23	Novo Nordisk Investigational Site	Athens	Georgia	United States	30606
24	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30318
25	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
26	Novo Nordisk Investigational Site	Savannah	Georgia	United States	31406
27	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
28	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60607
29	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60616
30	Novo Nordisk Investigational Site	Lafayette	Indiana	United States	47904
31	Novo Nordisk Investigational Site	Wichita	Kansas	United States	67226
32	Novo Nordisk Investigational Site	Bowling Green	Kentucky	United States	42101-1759
33	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
34	Novo Nordisk Investigational Site	Metairie	Louisiana	United States	70002
35	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21204
36	Novo Nordisk Investigational Site	Hyattsville	Maryland	United States	20782
37	Novo Nordisk Investigational Site	Rockville	Maryland	United States	20852
38	Novo Nordisk Investigational Site	Jefferson City	Missouri	United States	65109
39	Novo Nordisk Investigational Site	St. Louis	Missouri	United States	63141
40	Novo Nordisk Investigational Site	Butte	Montana	United States	59701
41	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68114
42	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89030
43	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89101
44	Novo Nordisk Investigational Site	Berlin	New Jersey	United States	08009
45	Novo Nordisk Investigational Site	Lawrenceville	New Jersey	United States	08648
46	Novo Nordisk Investigational Site	Asheville	North Carolina	United States	28803
47	Novo Nordisk Investigational Site	Tabor City	North Carolina	United States	28463
48	Novo Nordisk Investigational Site	Fargo	North Dakota	United States	58104
49	Novo Nordisk Investigational Site	Dayton	Ohio	United States	45439
50	Novo Nordisk Investigational Site	Gallipolis	Ohio	United States	45631-1560
51	Novo Nordisk Investigational Site	Kettering	Ohio	United States	45429
52	Novo Nordisk Investigational Site	Mentor	Ohio	United States	44060
53	Novo Nordisk Investigational Site	Medford	Oregon	United States	97504-8491
54	Novo Nordisk Investigational Site	Altoona	Pennsylvania	United States	16602
55	Novo Nordisk Investigational Site	Carlisle	Pennsylvania	United States	17015
56	Novo Nordisk Investigational Site	Little River	South Carolina	United States	29566
57	Novo Nordisk Investigational Site	Chattanooga	Tennessee	United States	37411
58	Novo Nordisk Investigational Site	Arlington	Texas	United States	76014
59	Novo Nordisk Investigational Site	Dallas	Texas	United States	75231
60	Novo Nordisk Investigational Site	Hurst	Texas	United States	76054
61	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229
62	Novo Nordisk Investigational Site	Ogden	Utah	United States	84403
63	Novo Nordisk Investigational Site	Virginia Beach	Virginia	United States	23462
64	Novo Nordisk Investigational Site	Renton	Washington	United States	98057
65	Novo Nordisk Investigational Site	Milwaukee	Wisconsin	United States	53209

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: NCT00773279
• Other Study ID Numbers: PDS290-1971
• First Posted: Oct 16, 2008
• Last Update Posted: Mar 27, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 61 sites in the United States of America (USA).
Pre-assignment Detail	Screening period of 2 weeks where the subjects were assessed for eligibility, run-in period of 6 weeks, hereafter eligible subjects were randomised to one of the two 12-week treatment sequences: PDS290 -> FlexPen® or FlexPen® -> PDS290.

Arm/Group Title	PDS290 -> FlexPen®	FlexPen® -> PDS290
Arm/Group Description
Period Title: Period 1
STARTED	121	121
COMPLETED	114	117
NOT COMPLETED	7	4
Period Title: Period 1
STARTED	114	117
COMPLETED	111	111
NOT COMPLETED	3	6

Baseline Characteristics

Arm/Group Title	Entire Trial Population
Arm/Group Description	Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
Overall Participants	242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (13.9)
Sex: Female, Male (Count of Participants)
Female	95 39.3%
Male	147 60.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 6.6%
Not Hispanic or Latino	226 93.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%
Asian	7 2.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	29 12%
White	199 82.2%
More than one race	0 0%
Unknown or Not Reported	6 2.5%
Region of Enrollment (participants) [Number]
United States	242 100%
HbA1c (glycosylated haemoglobin) (percentage (%) of total haemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage (%) of total haemoglobin]	7.3 (0.9)

Outcome Measures

1. Primary Outcome

Title	HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®
Time Frame	Week 12 of each treatment sequence

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) population comprising all randomised subjects and with data on HbA1c. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects dropped out during either treatment sequence.

Arm/Group Title	PDS290	FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
Measure Participants	232	233
Mean (Standard Deviation) [percentage (%) of total haemoglobin]	7.5 (1.0)	7.5 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PDS290, FlexPen®
	Comments	The null hypothesis is that PDS290 be not non-inferior to FlexPen® with respect to HbA1c after 12 weeks of treatment; non-inferiority margin is 0.4 % (absolute).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A two-sided 95 % Confidence Interval (CI) for the treatment difference, "PDS290 minus FlexPen", in HbA1c after 12 weeks of treatment. PDS290 was to be declared non-inferior to FlexPen® if the upper limit of that CI would be less than the non-inferiority margin 0.40 % (absolute).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.047
	Confidence Interval	() 95%; -0.127 to 0.032
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.040
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use
Description	Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT population. Some subjects did not have any available Niskanen Comparative Device Questionnaire results.

Arm/Group Title	Entire Trial Population
Arm/Group Description	Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
Measure Participants	227
Preference of PDS290	68 28.1%
Preference of FlexPen®	19 7.9%
No preference	13 5.4%

3. Secondary Outcome

Title	Summary Score for Treatment Satisfaction
Description	Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available ITSQ results in PDS290 and FlexPen® treatment groups, respectively.

Arm/Group Title	PDS290	FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
Measure Participants	222	223
Mean (Standard Deviation) [scores on a scale]	80.9 (11.3)	76.8 (15.2)

4. Secondary Outcome

Title	Score for Treatment Impact Measure for Diabetes
Description	Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any TRIM-D available results in PDS290 and FlexPen® treatment groups, respectively.

Arm/Group Title	PDS290	FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
Measure Participants	232	232
TRIM-D total scores	75.1 (13.1)	72.8 (13.6)
TRIM-D device scores	84.9 (12.7)	78.6 (16.6)

5. Secondary Outcome

Title	Clinical Technical Complaints (CTCs)
Description	A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.
Time Frame	Weeks 0-24 (whole trial period)

Outcome Measure Data

Analysis Population Description

ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.

Arm/Group Title	PDS290	FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
Measure Participants	242	242
Number [CTCs]	67	84

6. Secondary Outcome

Title	Number of Hypoglycaemic Episodes
Description	Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.
Time Frame	Weeks 0-12 (first treatment) and 12-24 (second treatment)

Outcome Measure Data

Analysis Population Description

ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.

Arm/Group Title	PDS290	FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
Measure Participants	239	235
All episodes	1108	1092
Major episodes	7	3
Minor episodes	920	927
Symptoms only	181	162

7. Secondary Outcome

Title	Number of Adverse Device Effects
Description	Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.
Time Frame	From randomisation (week 0) and until 7 days after Week 24 (Visit 16)

Outcome Measure Data

Analysis Population Description

ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.

Arm/Group Title	PDS290	FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
Measure Participants	239	235
Number [events]	0	0

8. Secondary Outcome

Title	Hypoglycaemic Episodes, Number of Events Per Subject Day
Time Frame	Weeks 0-12 (first treatment) and 12-24 (second treatment)

Outcome Measure Data

Analysis Population Description

ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).

Arm/Group Title	PDS290	FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
Measure Participants	239	235
Number [events per subject-day]	0.06	0.06

Adverse Events

Time Frame	From randomisation and until seven days after Week 24 (Visit 16).
Adverse Event Reporting Description	ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
Arm/Group Title	PDS290		FlexPen®
Arm/Group Description	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).		Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
All Cause Mortality
	PDS290		FlexPen®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PDS290		FlexPen®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/238 (2.9%)		5/235 (2.1%)
Cardiac disorders
Arrhythmia	0/238 (0%)	0	1/235 (0.4%)	1
Coronary Artery Disease	1/238 (0.4%)	1	0/235 (0%)	0
Cardiac failure congestive	1/238 (0.4%)	1	0/235 (0%)	0
Cardiac Failure	1/238 (0.4%)	1	0/235 (0%)	0
Gastrointestinal disorders
Colonic polyp	0/238 (0%)	0	1/235 (0.4%)	1
Gastroesophageal reflux disease	0/238 (0%)	0	1/235 (0.4%)	1
Injury, poisoning and procedural complications
Drug dispensing error	1/238 (0.4%)	1	0/235 (0%)	0
Metabolism and nutrition disorders
Hypoglycaemia	1/238 (0.4%)	2	1/235 (0.4%)	1
Diabetic ketoacidosis	0/238 (0%)	0	1/235 (0.4%)	1
Hypoglycaemic unconsciousness	1/238 (0.4%)	1	0/235 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant	1/238 (0.4%)	1	0/235 (0%)	0
Colon Cancer	1/238 (0.4%)	1	0/235 (0%)	0
Nervous system disorders
Ataxia	0/238 (0%)	0	1/235 (0.4%)	1
Renal and urinary disorders
Renal failure chronic	1/238 (0.4%)	1	0/235 (0%)	0
Other (Not Including Serious) Adverse Events
	PDS290		FlexPen®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/238 (10.5%)		31/235 (13.2%)
Infections and infestations
Nasopharyngitis	15/238 (6.3%)	19	20/235 (8.5%)	24
Upper Respiratory Tract Infection	11/238 (4.6%)	12	12/235 (5.1%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Novo Nordisk reserves the right not to release data until specified milestones, eg a clinical trial report is available. This includes the right not to release interim results from clinical trials, because such results may lead to conclusions that are later shown to be incorrect. Novo Nordisk will not suppress or veto publications; however Novo Nordisk reserves the right to postpone publication and/or communication for a short time to protect intellectual property.