Trial Outcomes & Findings for Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus (NCT NCT01226043)

Last Updated: 2013-08-12

Results Overview

The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d "Overall, what is your level of preference for each of the insulin delivery systems?" 5 points scale: from 1=Not preferred to 5= Always preferred

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

405 participants

Primary outcome timeframe

At week 4 (end of crossover phase)

Results posted on

2013-08-12

Participant Flow

Enrollment of patients started on October 26, 2010 and the study was completed on May 7, 2012. Patients were screened in 60 centers in the United States of America, of which 59 centers randomized patients.

A total 623 patients were screened of whom 405 insulin naïve patients were randomized for the crossover phase. The most common reason for non randomization was glycosylated hemoglobin (HbA1c) value out of range at the screening visit as defined per protocol.

Participant milestones

Participant milestones
Measure	Pen (Period 1) / Vial & Syringe (Period 2) Crossover phase: patients randomized to the sequence: Lantus SoloSTAR® pen in Period 1 and Lantus vial and syringe in Period 2.	Vial &Syringe (Period 1) / Pen (Period 2) Crossover phase: patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2.	SoloSTAR® Pen Re-randomization phase and the observational phase: patients randomized to Lantus SoloSTAR® pen.	Vial and Syringe Re-randomization phase and the observational phase: patients randomized to Lantus Vial and Syringe.
4-week Crossover Phase - Period 1 STARTED	202	203	0	0
4-week Crossover Phase - Period 1 TREATED	202	200	0	0
4-week Crossover Phase - Period 1 COMPLETED	199	194	0	0
4-week Crossover Phase - Period 1 NOT COMPLETED	3	9	0	0
4-week Crossover Phase - Period 2 STARTED	199	194	0	0
4-week Crossover Phase - Period 2 TREATED	199	194	0	0
4-week Crossover Phase - Period 2 COMPLETED	195	188	0	0
4-week Crossover Phase - Period 2 NOT COMPLETED	4	6	0	0
6-week Re-randomization Phase STARTED	0	0	166	167
6-week Re-randomization Phase TREATED	0	0	165	165
6-week Re-randomization Phase COMPLETED	0	0	159	156
6-week Re-randomization Phase NOT COMPLETED	0	0	7	11
30-week Observational Phase STARTED	0	0	159	153
30-week Observational Phase TREATED	0	0	159	153
30-week Observational Phase COMPLETED	0	0	153	140
30-week Observational Phase NOT COMPLETED	0	0	6	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Pen (Period 1) / Vial & Syringe (Period 2) Crossover phase: patients randomized to the sequence: Lantus SoloSTAR® pen in Period 1 and Lantus vial and syringe in Period 2.	Vial &Syringe (Period 1) / Pen (Period 2) Crossover phase: patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2.	SoloSTAR® Pen Re-randomization phase and the observational phase: patients randomized to Lantus SoloSTAR® pen.	Vial and Syringe Re-randomization phase and the observational phase: patients randomized to Lantus Vial and Syringe.
4-week Crossover Phase - Period 1 Protocol Violation	1	2	0	0
4-week Crossover Phase - Period 1 Lost to Follow-up	0	1	0	0
4-week Crossover Phase - Period 1 Withdrawal by Subject	2	0	0	0
4-week Crossover Phase - Period 1 Physician Decision	0	6	0	0
4-week Crossover Phase - Period 2 Withdrawal by Subject	0	1	0	0
4-week Crossover Phase - Period 2 Physician Decision	4	5	0	0
6-week Re-randomization Phase Adverse Event	0	0	1	1
6-week Re-randomization Phase Protocol Violation	0	0	1	1
6-week Re-randomization Phase Lost to Follow-up	0	0	1	3
6-week Re-randomization Phase Withdrawal by Subject	0	0	1	3
6-week Re-randomization Phase Physician Decision	0	0	3	2
6-week Re-randomization Phase completed in error	0	0	0	1
30-week Observational Phase Adverse Event	0	0	1	1
30-week Observational Phase Protocol Violation	0	0	0	1
30-week Observational Phase Lost to Follow-up	0	0	2	2
30-week Observational Phase Withdrawal by Subject	0	0	1	7
30-week Observational Phase Physician Decision	0	0	2	2

Baseline Characteristics

Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crossover Phase: Pen / Vial & Syringe n=202 Participants Patients randomized to the sequence: Lantus SoloSTAR pen in Period 1 and Lantus vial and syringe in Period 2 for the 4-week crossover phase.	Crossover Phase: Vial & Syringe / Pen n=203 Participants Patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2 for the 4-week crossover phase.	Total n=405 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	153 Participants n=5 Participants	146 Participants n=7 Participants	299 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	57 Participants n=7 Participants	106 Participants n=5 Participants
Age Continuous	57.7 years STANDARD_DEVIATION 10.1 • n=5 Participants	58.1 years STANDARD_DEVIATION 10.9 • n=7 Participants	57.9 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	88 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	115 Participants n=7 Participants	217 Participants n=5 Participants
Body Weight	103.80 kg STANDARD_DEVIATION 26.43 • n=5 Participants	98.48 kg STANDARD_DEVIATION 20.75 • n=7 Participants	101.13 kg STANDARD_DEVIATION 23.87 • n=5 Participants
Body Mass Index	35.93 kg/m^2 STANDARD_DEVIATION 7.87 • n=5 Participants	33.73 kg/m^2 STANDARD_DEVIATION 6.64 • n=7 Participants	34.83 kg/m^2 STANDARD_DEVIATION 7.35 • n=5 Participants

PRIMARY outcome

Timeframe: At week 4 (end of crossover phase)

Population: The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered question 14d.

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=388 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=388 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Patient Overall Preference	4.75 units on a scale 95% Confidence Interval 4.75 • Interval 4.65 to 4.85	2.45 units on a scale Interval 2.35 to 2.56	—	—	—	—

SECONDARY outcome

Timeframe: At week 4 (end of crossover phase)

The patient preference composite score was the sum of the scores of the 3 following individual preference questions from the Patient preference Questionnaire: * Question 14a: How strongly do you prefer each of these insulin delivery systems to control blood sugar? * Question 14b: If using insulin for the first time, how strongly would you prefer using each of these delivery systems to overcome reluctance to use insulin? * Question 14c: How strongly would you prefer each insulin delivery system for long-term use? Each individual question scored from 1 to 5. The lowest score 1 indicated 'Not Preferred' and the highest score 5 indicated 'Always Preferred'. Therefore the total range of the composite score was 3 to 15.

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=384 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=384 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Patient Preference Composite Score	14.2 units on a scale Interval 13.88 to 14.44	7.49 units on a scale Interval 7.21 to 7.77	—	—	—	—

SECONDARY outcome

Timeframe: At week 4 (end of crossover phase)

Population: The HCP Questionnaire analysis population consisted of HCPs: * who treated at least 1 randomized patient during the crossover phase and this(these) patient(s) received at least one dose of Lantus via both insulin delivery systems during the crossover phase * who completed the HCP Questionnaire.

The overall recommendation score was obtained from the question 20d of the Healthcare Professional Questionnaire: "Overall, how strongly would you recommend each of the insulin delivery systems for your patients?" 5 points scale: from 1= Not Recommended to 5= Recommended

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=135 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=135 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Healthcare Professional's (HCP) Recommendation	5.0 units on a scale Interval 4.0 to 5.0	3.0 units on a scale Interval 1.0 to 5.0	—	—	—	—

SECONDARY outcome

Timeframe: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)

Population: The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG measured during the on-treatment period.

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=154 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=150 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Change in Fasting Plasma Glucose (FPG)	-14.3 mg/dL Standard Error 2.87	-14.5 mg/dL Standard Error 2.91	—	—	—	—

SECONDARY outcome

Timeframe: At week 10 (end of re-randomization phase)

Population: The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had a re-randomization baseline assessment FPG \> or = 110 (week 4) and at least one post re-randomization assessment of FPG.

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=125 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=128 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL	28.8 percentage of patients	30.5 percentage of patients	—	—	—	—

SECONDARY outcome

Timeframe: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=159 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=155 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Change in Lantus Dose Injected Per Day	6.361 U (insulin unit) Standard Error 0.786	6.336 U (insulin unit) Standard Error 0.796	—	—	—	—

SECONDARY outcome

Timeframe: measured at week 40 or at study discontinuation

Population: Patients from the mITT population for Re-randomization and Observational Phases who had at least one post re-randomization assessment of HbA1c.

Percentage of patients achieving HbA1c \< 7% at Week 40 (end of the observational phase)

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=159 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=154 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Percentage of Patients Achieving HbA1c Goal	37.7 percentage of patients	37.0 percentage of patients	—	—	—	—

SECONDARY outcome

Timeframe: From week 10 to week 40 (observational phase)

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=155 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=149 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Time to First Observation of HbA1c <7%	166 Days since Re-randomization (week 4) Interval 88.0 to 248.0	168 Days since Re-randomization (week 4) Interval 91.0 to 250.0	—	—	—	—

SECONDARY outcome

Timeframe: From baseline to week 4 (crossover phase)

Population: Randomized population (crossover phase) exposed to at least one dose of the IP

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=202 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=199 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) n=194 Participants Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) n=200 Participants Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase	1.49 percentage of patients	2.01 percentage of patients	3.09 percentage of patients	3.00 percentage of patients	—	—

SECONDARY outcome

Timeframe: From week 4 to week 10 (re-randomization phase)

Population: Re-randomized population at week 4 exposed to at least one dose of the IP

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=165 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=165 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase	3.6 percentage of patients	5.5 percentage of patients	—	—	—	—

SECONDARY outcome

Timeframe: From week 10 to week 40 (observational phase)

Population: Re-randomized population at week 4 and included in the observational phase at week 10 and exposed to at least one dose of the IP

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=159 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=153 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase	3.8 percentage of patients	8.5 percentage of patients	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: each study phase (crossover, re-randomization, observational) up to 40 weeks

Population: The safety population for each phase (crossover, re-randomization, observational) was the total treated population defined as all the patients who were randomized and exposed to at least one dose of Lantus during that phase.

The hypoglycemic event was to be recorded on the electronic case report form hypoglycemia page and had to fit in one of the following categories: Mild-to-moderate hypoglycemia (36 mg/dL ≤ Self Monitored Blood Glucose (SMBG) \<70mg/dL), Severe hypoglycemia (assistance of another person is required, and either a recorded SMBG \<36 mg/dL, or treatment with oral carbohydrates, intravenous glucose or glucagon with prompt response) or Hypoglycemia symptoms with or without SMBG values with a documented SMBG \>70 mg/dL, or no recorded SMBG value. Only hypoglycemia events associated with coma, loss of consciousness or seizure were considered serious adverse event (SAEs).

Outcome measures

Outcome measures
Measure	SoloSTAR® Pen n=396 Participants Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Vial and Syringe n=399 Participants Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	SoloSTAR® Pen (Period 2) n=165 Participants Patients using SoloSTAR® pen during period 2 of the crossover phase.	Vial and Syringe (Period 1) n=165 Participants Patients using Vial and Syringe during period 1 of the crossover phase.	Observational Phase: SoloSTAR® Pen n=159 Participants Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe n=153 Participants Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Number of Patients With Hypoglycemic Events Hypoglycemic event with or without SMBG	72 participants having reported the event	83 participants having reported the event	43 participants having reported the event	48 participants having reported the event	76 participants having reported the event	73 participants having reported the event
Number of Patients With Hypoglycemic Events Hypoglycemia with SMBG	69 participants having reported the event	81 participants having reported the event	38 participants having reported the event	47 participants having reported the event	75 participants having reported the event	71 participants having reported the event
Number of Patients With Hypoglycemic Events Symptomatic hypoglycemia	57 participants having reported the event	68 participants having reported the event	37 participants having reported the event	37 participants having reported the event	61 participants having reported the event	61 participants having reported the event
Number of Patients With Hypoglycemic Events Hypoglycemia, assistance required	3 participants having reported the event	2 participants having reported the event	2 participants having reported the event	5 participants having reported the event	8 participants having reported the event	11 participants having reported the event
Number of Patients With Hypoglycemic Events Severe hypoglycemia	3 participants having reported the event	2 participants having reported the event	2 participants having reported the event	4 participants having reported the event	7 participants having reported the event	11 participants having reported the event
Number of Patients With Hypoglycemic Events Serious hypoglycemia	0 participants having reported the event	0 participants having reported the event	0 participants having reported the event	0 participants having reported the event	0 participants having reported the event	0 participants having reported the event

Adverse Events

Crossover Phase: SoloSTAR® Pen

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Crossover Phase: Vial and Syringe

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Re-randomization Phase: SoloSTAR® Pen

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Re-randomization Phase: Vial and Syringe

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Observational Phase: SoloSTAR® Pen

Serious events: 16 serious events

Other events: 35 other events

Deaths: 0 deaths

Observational Phase: Vial and Syringe

Serious events: 14 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Crossover Phase: SoloSTAR® Pen n=396 participants at risk Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Crossover Phase: Vial and Syringe n=399 participants at risk Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Re-randomization Phase: SoloSTAR® Pen n=165 participants at risk Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)	Re-randomization Phase: Vial and Syringe n=165 participants at risk Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)	Observational Phase: SoloSTAR® Pen n=159 participants at risk Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe n=153 participants at risk Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Angina pectoris	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Angina unstable	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Respiratory, thoracic and mediastinal disorders Asthma	0.25% 1/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Atrial fibrillation	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	1.3% 2/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Psychiatric disorders Bipolar I disorder	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Reproductive system and breast disorders Breast calcifications	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Renal and urinary disorders Calculus ureteric	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Cardiac failure congestive	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Cauda equina syndrome	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.61% 1/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Cellulitis	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Cerebrovascular accident	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Chest pain	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Chronic obstructive pulmonary disease	0.25% 1/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Colon neoplasm	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Diarrhoea	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Duodenal ulcer	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Duodenal ulcer haemorrhage	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Cardiac disorders Dyspnoea	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
General disorders Hypercalcaemia	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Injury, poisoning and procedural complications Intracranial aneurysm	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Musculoskeletal and connective tissue disorders Myocardial infarction	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Musculoskeletal and connective tissue disorders Myocardial ischaemia	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nephrolithiasis	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Nervous system disorders Non-cardiac chest pain	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	1.3% 2/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Nervous system disorders Osteomyelitis	0.25% 1/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Nervous system disorders Pancreatic mass	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.25% 1/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Nervous system disorders Pneumonia	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Nervous system disorders Post procedural complication	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.61% 1/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Renal and urinary disorders Renal failure	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Respiratory, thoracic and mediastinal disorders Road traffic accident	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Respiratory, thoracic and mediastinal disorders Staphylococcal infection	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Surgical and medical procedures Syncope	0.25% 1/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Surgical and medical procedures Transurethral bladder resection	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Surgical and medical procedures Urethral obstruction	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.63% 1/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Surgical and medical procedures Uterine haemorrhage	0.00% 0/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.65% 1/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.

Other adverse events

Other adverse events
Measure	Crossover Phase: SoloSTAR® Pen n=396 participants at risk Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Crossover Phase: Vial and Syringe n=399 participants at risk Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.	Re-randomization Phase: SoloSTAR® Pen n=165 participants at risk Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)	Re-randomization Phase: Vial and Syringe n=165 participants at risk Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)	Observational Phase: SoloSTAR® Pen n=159 participants at risk Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)	Observational Phase: Vial and Syringe n=153 participants at risk Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
Infections and infestations Nasopharyngitis	1.3% 5/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	3.6% 6/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	2.4% 4/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	4.4% 7/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	8.5% 13/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Infections and infestations Sinusitis	1.0% 4/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.25% 1/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	1.2% 2/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	3.6% 6/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	7.5% 12/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	3.9% 6/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
Infections and infestations Upper respiratory tract infection	1.8% 7/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.50% 2/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	2.4% 4/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.61% 1/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	8.8% 14/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	7.8% 12/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.
General disorders Oedema peripheral	0.51% 2/396 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.50% 2/399 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	0.00% 0/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	1.8% 3/165 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	5.0% 8/159 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.	2.0% 3/153 • The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.

Additional Information

Trial Transparency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER