Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM) Secondary Objectives: To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters: Randomization/Crossover phase: * Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe Re-randomization phase: * Change in Fasting Plasma Glucose (FPG) from week 4 to week 10 * Percentage of patients achieving FPG\<110 mg/dL at week 10 * Change in Lantus dose injected per day (U) from week 4 to week 10 Observational phase: * Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (\<7%) at week 40 * Time to first observation of HbA1c\<7% during the observational phase * Percentage of patients who discontinue Investigational Product (IP) during the observational phase due to dissatisfaction with their current device All phases: * Percentage of patients who discontinue IP during each phase of the study * Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)
Detailed description
This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a 6-week Re-randomization Phase, followed by a 30 week Observational Phase. The total duration of study participation was up to 41 weeks with a total treatment duration of up to 40 weeks of Lantus exposure.
Interventions
DRUGInsulin Glargine
* Pharmaceutical form: solution for injection * Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with a confirmed diagnosis of type 2 diabetes mellitus who were treated with any combination of 2 or 3 oral antidiabetic drugs (OADs) at a stable dose for the preceding 3 months, including but not limited to: * Metformin + sulfonylurea + thiazolidinedione (Pioglitazone) * Metformin + sulfonylurea * Metformin + thiazolidinedione (Pioglitazone) * Metformin + dipeptidyl peptidase (DPPIV) And for whom the Investigator/treating physician had decided that basal insulin was appropriate. Patients who had signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form
Exclusion criteria
* Patients less than 18 years or greater than 85 years of age (ie, have not reached the age of 86 at the screening visit) * Patients with a confirmed diagnosis of type 1 diabetes mellitus * Patients who were treated with insulin or who had been treated with insulin in the preceding 12 months with the exception of insulin treatment during hospitalization (ie, patients who received insulin while hospitalized could be included) * Patients whose screening HbA1c is \<7% or \>10% * Patients with current addiction or current alcohol / drug abuse * Patients with cardiac status New York Heart Association III-IV * Patients with stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or unstable angina pectoris within the 12 months prior to screening * Patients with a diagnosis of dementia, severe visual or dexterity impairment * Patients with any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ * Patients with concomitant disease or concomitant medication that could interfere with treatment or ability to answer questionnaires * Patients who were unable to self-inject * Patients who were taking or had been treated with Byetta® (exenatide) or other Glucagon-Like Peptide-1 agonists within 3 months before screening: * Patients who were pregnant or breastfeeding * Women of childbearing potential not protected by a highly effective contraceptive method of birth control (as defined for contraception in the Informed Consent Form and /or in a local protocol addendum) and/or who were unwilling or unable to be tested for pregnancy * Patients with impaired renal function as shown by serum creatinine ≥1.5 mg/dL for males or ≥1.4 mg/dL for females at screening * Patients with clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range (ULN) * Patients unlikely to comply with the protocol requirements (eg, illiterate, uncooperative, unable to return for scheduled visits, unlikely to complete the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Overall Preference | At week 4 (end of crossover phase) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference Composite Score | 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. |
| Healthcare Professional's (HCP) Recommendation | At week 4 (end of crossover phase) | 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 |
| Change in Fasting Plasma Glucose (FPG) | From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase) | — |
| Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL | At week 10 (end of re-randomization phase) | — |
| Change in Lantus Dose Injected Per Day | From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase) | — |
| Time to First Observation of HbA1c <7% | From week 10 to week 40 (observational phase) | — |
| Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase | From baseline to week 4 (crossover phase) | — |
| Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase | From week 4 to week 10 (re-randomization phase) | — |
| Percentage of Patients Who Discontinued Investigational Product During the Observational Phase | From week 10 to week 40 (observational phase) | — |
| Percentage of Patients Achieving HbA1c Goal | measured at week 40 or at study discontinuation | Percentage of patients achieving HbA1c \< 7% at Week 40 (end of the observational phase) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Hypoglycemic Events | each study phase (crossover, re-randomization, observational) up to 40 weeks | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Crossover Phase: Pen / Vial & Syringe 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. | 202 |
| Crossover Phase: Vial & Syringe / Pen 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. | 203 |
| Total | 405 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 30-week Observational Phase | Adverse Event | 0 | 0 | 1 | 1 |
| 30-week Observational Phase | Lost to Follow-up | 0 | 0 | 2 | 2 |
| 30-week Observational Phase | Physician Decision | 0 | 0 | 2 | 2 |
| 30-week Observational Phase | Protocol Violation | 0 | 0 | 0 | 1 |
| 30-week Observational Phase | Withdrawal by Subject | 0 | 0 | 1 | 7 |
| 4-week Crossover Phase - Period 1 | Lost to Follow-up | 0 | 1 | 0 | 0 |
| 4-week Crossover Phase - Period 1 | Physician Decision | 0 | 6 | 0 | 0 |
| 4-week Crossover Phase - Period 1 | Protocol Violation | 1 | 2 | 0 | 0 |
| 4-week Crossover Phase - Period 1 | Withdrawal by Subject | 2 | 0 | 0 | 0 |
| 4-week Crossover Phase - Period 2 | Physician Decision | 4 | 5 | 0 | 0 |
| 4-week Crossover Phase - Period 2 | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| 6-week Re-randomization Phase | Adverse Event | 0 | 0 | 1 | 1 |
| 6-week Re-randomization Phase | completed in error | 0 | 0 | 0 | 1 |
| 6-week Re-randomization Phase | Lost to Follow-up | 0 | 0 | 1 | 3 |
| 6-week Re-randomization Phase | Physician Decision | 0 | 0 | 3 | 2 |
| 6-week Re-randomization Phase | Protocol Violation | 0 | 0 | 1 | 1 |
| 6-week Re-randomization Phase | Withdrawal by Subject | 0 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Crossover Phase: Pen / Vial & Syringe | Crossover Phase: Vial & Syringe / Pen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 57 Participants | 106 Participants |
| Age, Categorical Between 18 and 65 years | 153 Participants | 146 Participants | 299 Participants |
| Age Continuous | 57.7 years STANDARD_DEVIATION 10.1 | 58.1 years STANDARD_DEVIATION 10.9 | 57.9 years STANDARD_DEVIATION 10.5 |
| Body Mass Index | 35.93 kg/m^2 STANDARD_DEVIATION 7.87 | 33.73 kg/m^2 STANDARD_DEVIATION 6.64 | 34.83 kg/m^2 STANDARD_DEVIATION 7.35 |
| Body Weight | 103.80 kg STANDARD_DEVIATION 26.43 | 98.48 kg STANDARD_DEVIATION 20.75 | 101.13 kg STANDARD_DEVIATION 23.87 |
| Sex: Female, Male Female | 100 Participants | 88 Participants | 188 Participants |
| Sex: Female, Male Male | 102 Participants | 115 Participants | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 396 | 5 / 399 | 12 / 165 | 14 / 165 | 35 / 159 | 34 / 153 |
| serious Total, serious adverse events | 4 / 396 | 1 / 399 | 1 / 165 | 0 / 165 | 16 / 159 | 14 / 153 |
Outcome results
Primary
Patient Overall Preference
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
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SoloSTAR® Pen | Patient Overall Preference | 4.75 units on a scale | 95% Confidence Interval 4.75 |
| Vial and Syringe | Patient Overall Preference | 2.45 units on a scale | — |
Comparison: The hypothesis was to determine whether patients have higher preference score for Lantus® SoloSTAR® pen compared to Lantus® vial/syringe. Differences of patient preference score greater than 0.5 were considered clinically meaningful. The power for detecting a true difference of 0.5 considering a standard deviation from 1.6 to 2.5, assuming 130 evaluable patients per arm and a two-sided test at 0.05 significance level ranged from 89% to more than 99%.p-value: <0.000195% CI: [2.15, 2.44]ANOVA
Secondary
Change in Fasting Plasma Glucose (FPG)
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SoloSTAR® Pen | Change in Fasting Plasma Glucose (FPG) | -14.3 mg/dL | Standard Error 2.87 |
| Vial and Syringe | Change in Fasting Plasma Glucose (FPG) | -14.5 mg/dL | Standard Error 2.91 |
Secondary
Change in Lantus Dose Injected Per Day
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SoloSTAR® Pen | Change in Lantus Dose Injected Per Day | 6.361 U (insulin unit) | Standard Error 0.786 |
| Vial and Syringe | Change in Lantus Dose Injected Per Day | 6.336 U (insulin unit) | Standard Error 0.796 |
Secondary
Healthcare Professional's (HCP) Recommendation
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
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SoloSTAR® Pen | Healthcare Professional's (HCP) Recommendation | 5.0 units on a scale |
| Vial and Syringe | Healthcare Professional's (HCP) Recommendation | 3.0 units on a scale |
Secondary
Patient Preference Composite Score
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.
Time frame: 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 to the 3 questions 14a, 14b and 14c.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SoloSTAR® Pen | Patient Preference Composite Score | 14.2 units on a scale |
| Vial and Syringe | Patient Preference Composite Score | 7.49 units on a scale |
Secondary
Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SoloSTAR® Pen | Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL | 28.8 percentage of patients |
| Vial and Syringe | Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL | 30.5 percentage of patients |
Secondary
Percentage of Patients Achieving HbA1c Goal
Percentage of patients achieving HbA1c \< 7% at Week 40 (end of the observational phase)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SoloSTAR® Pen | Percentage of Patients Achieving HbA1c Goal | 37.7 percentage of patients |
| Vial and Syringe | Percentage of Patients Achieving HbA1c Goal | 37.0 percentage of patients |
Secondary
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SoloSTAR® Pen | Percentage of Patients Who Discontinued Investigational Product During the Observational Phase | 3.8 percentage of patients |
| Vial and Syringe | Percentage of Patients Who Discontinued Investigational Product During the Observational Phase | 8.5 percentage of patients |
Secondary
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SoloSTAR® Pen | Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase | 3.6 percentage of patients |
| Vial and Syringe | Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase | 5.5 percentage of patients |
Secondary
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase
Time frame: From baseline to week 4 (crossover phase)
Population: Randomized population (crossover phase) exposed to at least one dose of the IP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SoloSTAR® Pen | Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase | 1.49 percentage of patients |
| Vial and Syringe | Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase | 2.01 percentage of patients |
| SoloSTAR® Pen (Period 2) | Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase | 3.09 percentage of patients |
| Vial and Syringe (Period 1) | Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase | 3.00 percentage of patients |
Secondary
Time to First Observation of HbA1c <7%
Time frame: From week 10 to week 40 (observational 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 HbA1c.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SoloSTAR® Pen | Time to First Observation of HbA1c <7% | 166 Days since Re-randomization (week 4) |
| Vial and Syringe | Time to First Observation of HbA1c <7% | 168 Days since Re-randomization (week 4) |
Other Pre-specified
Number of Patients With Hypoglycemic Events
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Hypoglycemic event with or without SMBG | 72 participants having reported the event |
| SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Hypoglycemia with SMBG | 69 participants having reported the event |
| SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Symptomatic hypoglycemia | 57 participants having reported the event |
| SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Hypoglycemia, assistance required | 3 participants having reported the event |
| SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Severe hypoglycemia | 3 participants having reported the event |
| SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Serious hypoglycemia | 0 participants having reported the event |
| Vial and Syringe | Number of Patients With Hypoglycemic Events | Hypoglycemia with SMBG | 81 participants having reported the event |
| Vial and Syringe | Number of Patients With Hypoglycemic Events | Hypoglycemia, assistance required | 2 participants having reported the event |
| Vial and Syringe | Number of Patients With Hypoglycemic Events | Serious hypoglycemia | 0 participants having reported the event |
| Vial and Syringe | Number of Patients With Hypoglycemic Events | Hypoglycemic event with or without SMBG | 83 participants having reported the event |
| Vial and Syringe | Number of Patients With Hypoglycemic Events | Symptomatic hypoglycemia | 68 participants having reported the event |
| Vial and Syringe | Number of Patients With Hypoglycemic Events | Severe hypoglycemia | 2 participants having reported the event |
| SoloSTAR® Pen (Period 2) | Number of Patients With Hypoglycemic Events | Serious hypoglycemia | 0 participants having reported the event |
| SoloSTAR® Pen (Period 2) | Number of Patients With Hypoglycemic Events | Severe hypoglycemia | 2 participants having reported the event |
| SoloSTAR® Pen (Period 2) | Number of Patients With Hypoglycemic Events | Hypoglycemia, assistance required | 2 participants having reported the event |
| SoloSTAR® Pen (Period 2) | Number of Patients With Hypoglycemic Events | Symptomatic hypoglycemia | 37 participants having reported the event |
| SoloSTAR® Pen (Period 2) | Number of Patients With Hypoglycemic Events | Hypoglycemic event with or without SMBG | 43 participants having reported the event |
| SoloSTAR® Pen (Period 2) | Number of Patients With Hypoglycemic Events | Hypoglycemia with SMBG | 38 participants having reported the event |
| Vial and Syringe (Period 1) | Number of Patients With Hypoglycemic Events | Hypoglycemia, assistance required | 5 participants having reported the event |
| Vial and Syringe (Period 1) | Number of Patients With Hypoglycemic Events | Hypoglycemia with SMBG | 47 participants having reported the event |
| Vial and Syringe (Period 1) | Number of Patients With Hypoglycemic Events | Symptomatic hypoglycemia | 37 participants having reported the event |
| Vial and Syringe (Period 1) | Number of Patients With Hypoglycemic Events | Serious hypoglycemia | 0 participants having reported the event |
| Vial and Syringe (Period 1) | Number of Patients With Hypoglycemic Events | Severe hypoglycemia | 4 participants having reported the event |
| Vial and Syringe (Period 1) | Number of Patients With Hypoglycemic Events | Hypoglycemic event with or without SMBG | 48 participants having reported the event |
| Observational Phase: SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Hypoglycemic event with or without SMBG | 76 participants having reported the event |
| Observational Phase: SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Severe hypoglycemia | 7 participants having reported the event |
| Observational Phase: SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Hypoglycemia with SMBG | 75 participants having reported the event |
| Observational Phase: SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Symptomatic hypoglycemia | 61 participants having reported the event |
| Observational Phase: SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Hypoglycemia, assistance required | 8 participants having reported the event |
| Observational Phase: SoloSTAR® Pen | Number of Patients With Hypoglycemic Events | Serious hypoglycemia | 0 participants having reported the event |
| Observational Phase: Vial and Syringe | Number of Patients With Hypoglycemic Events | Hypoglycemia, assistance required | 11 participants having reported the event |
| Observational Phase: Vial and Syringe | Number of Patients With Hypoglycemic Events | Symptomatic hypoglycemia | 61 participants having reported the event |
| Observational Phase: Vial and Syringe | Number of Patients With Hypoglycemic Events | Severe hypoglycemia | 11 participants having reported the event |
| Observational Phase: Vial and Syringe | Number of Patients With Hypoglycemic Events | Serious hypoglycemia | 0 participants having reported the event |
| Observational Phase: Vial and Syringe | Number of Patients With Hypoglycemic Events | Hypoglycemia with SMBG | 71 participants having reported the event |
| Observational Phase: Vial and Syringe | Number of Patients With Hypoglycemic Events | Hypoglycemic event with or without SMBG | 73 participants having reported the event |