Efficacy, Safety and Preference Study of a Insulin Pen PD... | NCT00773279

NCT00773279

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PDS290 --> FlexPen®	Experimental	Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2)	Device: FlexTouch® Device: FlexPen®
FlexPen® --> PDS290	Experimental	Subjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2)	Device: FlexTouch® Device: FlexPen®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FlexTouch®	Device	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.

Outcomes Module

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

Secondary Outcomes

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

Eligibility Module

Eligibility Criteria

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/Locations Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Burlingame	California	94010	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21883036	Result	Wielandt JO, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen. Expert Opin Drug Deliv. 2011 Oct;8(10):1271-6. doi: 10.1517/17425247.2011.615308. Epub 2011 Sep 2.
21988614	Result

Label	URL
Clinical Trials at Novo Nordisk	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	PDS290 -> FlexPen®
FG001	FlexPen® -> PDS290

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Entire Trial Population	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058± 13.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00095
Male	BG000147

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00016
Not Hispanic or Latino	BG000226

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG0007

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000242

HbA1c (glycosylated haemoglobin)

Mean

Standard Deviation

percentage (%) of total haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0007.3± 0.9

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®

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.

Posted

Mean

Standard Deviation

percentage (%) of total haemoglobin

Week 12 of each treatment sequence

ID	Title	Description
OG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
OG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.

Units	Counts
Participants	OG000232 OG001233

Title

Denominators

Categories

Title	Measurements
	OG0007.5± 1.0 OG0017.5± 1.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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).	Linear mixed effect model	Linear mixed effect model with period and delivery systems as fixed effects, and subject as a random effect.			Mean Difference (Final Values)	-0.047	Standard Error of the Mean	0.040		95	-0.127	0.032					Non-Inferiority or Equivalence	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).

Secondary

Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use

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

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

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Entire Trial Population	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.

Units	Counts
Participants	OG000

Secondary

Summary Score for Treatment Satisfaction

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

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.

Posted

Mean

Standard Deviation

scores on a scale

Week 24

ID	Title	Description
OG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
OG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.

Units	Counts
Participants	OG000

Secondary

Score for Treatment Impact Measure for Diabetes

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

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.

Posted

Mean

Standard Deviation

scores on a scale

Week 24

ID	Title	Description
OG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
OG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.

Units	Counts
Participants	OG000

Secondary

Clinical Technical Complaints (CTCs)

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.

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.

Posted

Number

CTCs

Weeks 0-24 (whole trial period)

ID	Title	Description
OG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
OG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.

Units	Counts
Participants	OG000

Secondary

Number of Hypoglycaemic Episodes

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.

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.

Posted

Number

episodes

Weeks 0-12 (first treatment) and 12-24 (second treatment)

ID	Title	Description
OG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
OG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.

Units	Counts
Participants	OG000

Secondary

Number of Adverse Device Effects

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.

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.

Posted

Number

events

From randomisation (week 0) and until 7 days after Week 24 (Visit 16)

ID	Title	Description
OG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
OG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.

Units	Counts
Participants

Secondary

Hypoglycaemic Episodes, Number of Events Per Subject Day

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®).

Posted

Number

events per subject-day

Weeks 0-12 (first treatment) and 12-24 (second treatment)

ID	Title	Description
OG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
OG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PDS290	Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).			7	238	25	238
EG001	FlexPen®	Participants who received usual insulin treatment with pre-filled pen device FlexPen®.			5	235	31	235

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Colonic polyp	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected235 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected238 at risk EG0011 events1 affected235 at risk
Arrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected235 at risk
Ataxia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected235 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected235 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected238 at risk EG0011 events1 affected235 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk
Drug dispensing error	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk
Cardiac Failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected238 at risk EG0010 events0 affected235 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG00019 events15 affected238 at risk EG00124 events20 affected235 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG00012 events11 affected238 at risk EG00113 events12 affected235 at risk

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases