Trial Outcomes & Findings for Mylan Insulin Aspart Study (NCT NCT03760068)
NCT ID: NCT03760068
Last Updated: 2022-02-25
Results Overview
The number of subjects who were TEAR positive. TEAR is defined as either one of the following: 1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline 2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
478 participants
Primary outcome timeframe
Baseline to week 24
Results posted on
2022-02-25
Participant Flow
Participant milestones
| Measure |
MYL-1601D Product (100 U/mL)
MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Overall Study
STARTED
|
238
|
240
|
|
Overall Study
COMPLETED
|
224
|
217
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
Reasons for withdrawal
| Measure |
MYL-1601D Product (100 U/mL)
MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Administrative Decision by Sponsor
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
9
|
|
Overall Study
Subject Moved Out of State
|
1
|
0
|
Baseline Characteristics
Mylan Insulin Aspart Study
Baseline characteristics by cohort
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog® (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
Total
n=478 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
238 Participants
n=99 Participants
|
240 Participants
n=107 Participants
|
478 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
261 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
210 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
420 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Screening Body Mass Index
|
27.56 kg/m^2
STANDARD_DEVIATION 4.221 • n=99 Participants
|
27.00 kg/m^2
STANDARD_DEVIATION 4.191 • n=107 Participants
|
27.28 kg/m^2
STANDARD_DEVIATION 4.211 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: Type 1 Diabetes Patients
The number of subjects who were TEAR positive. TEAR is defined as either one of the following: 1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline 2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
Outcome measures
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Treatment Emergent Antibody Response (TEAR)
|
59 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: Type 1 Diabetes Patients
Mean (SD) change from baseline HbA1c at Week 24.
Outcome measures
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Change in HbA1c From Baseline
|
0.10 percentage of change
Standard Deviation 0.735
|
0.04 percentage of change
Standard Deviation 0.723
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: Type 1 Diabetes Patients
Mean (SD) change from baseline plasma glucose at Week 24.
Outcome measures
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline
|
0.400 mmol/L
Standard Deviation 5.8162
|
0.599 mmol/L
Standard Deviation 5.1553
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: Type 1 Diabetes Patients
Mean (SD) change from baseline daily mealtime insulin dose at Week 24.
Outcome measures
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Change in Prandial Insulin Dose From Baseline
|
0.0079 U/kg)
Standard Deviation 0.14608
|
-0.0008 U/kg)
Standard Deviation 0.09731
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: Type 1 Diabetes Patients
Mean (SD) change from baseline total daily insulin dose at Week 24.
Outcome measures
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Change in Basal Insulin Dose From Baseline
|
0.0053 U/kg
Standard Deviation 0.06459
|
0.0001 U/kg
Standard Deviation 0.05152
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: Type 1 Diabetes Patients
Mean (SD) change from baseline total daily insulin dose at Week 24
Outcome measures
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Change in Total Daily Insulin Dose From Baseline
|
0.0178 U/kg
Standard Deviation 0.15888
|
0.0024 U/kg
Standard Deviation 0.10649
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: Type 1 Diabetes Patients
Mean (SD) change in 7-point SMBG profile from baseline to Week 24
Outcome measures
| Measure |
MYL-1601D Product (100 U/mL)
n=238 Participants
MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 Participants
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline
|
0.1180 mmol/L)
Standard Deviation 2.09287
|
0.0999 mmol/L)
Standard Deviation 1.86471
|
Adverse Events
MYL-1601D Product (100 U/mL)
Serious events: 22 serious events
Other events: 92 other events
Deaths: 0 deaths
FlexPen NovoLog® (100 U/mL)
Serious events: 15 serious events
Other events: 99 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MYL-1601D Product (100 U/mL)
n=238 participants at risk
MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 participants at risk
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Gastrointestinal disorders
Colititis
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
General disorders
Chest Pain
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Anal Abscess
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Incision Site Cellulitis
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Perineal Abscess
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.3%
15/238 • Number of events 18 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
4.2%
10/240 • Number of events 12 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Nervous system disorders
Hypoglycemic Seizure
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Social circumstances
Victim of Homicide
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
Other adverse events
| Measure |
MYL-1601D Product (100 U/mL)
n=238 participants at risk
MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
FlexPen NovoLog® (100 U/mL)
n=240 participants at risk
FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.
Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.2%
3/240 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
6/238 • Number of events 6 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.83%
2/240 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
4/238 • Number of events 4 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.83%
2/240 • Number of events 2 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Gastrointestinal disorders
Food Poisoning
|
1.3%
3/238 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.83%
2/240 • Number of events 2 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
3/238 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
1.3%
3/238 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
General disorders
Fatigue
|
1.3%
3/238 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.2%
3/240 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
14/238 • Number of events 15 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
6.2%
15/240 • Number of events 19 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.6%
11/238 • Number of events 16 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
5.8%
14/240 • Number of events 16 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
3.8%
9/238 • Number of events 10 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
3.8%
9/240 • Number of events 11 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
3.3%
8/240 • Number of events 10 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.7%
4/240 • Number of events 4 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.2%
3/240 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Investigations
Weight Increased
|
1.3%
3/238 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.7%
4/240 • Number of events 4 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Investigations
Blood Pressure Increased
|
1.3%
3/238 • Number of events 5 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.2%
3/240 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Investigations
Glycosylated Hemoglobin Increased
|
1.3%
3/238 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.42%
1/240 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Investigations
Crystal Urine Present
|
0.00%
0/238 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.2%
3/240 • Number of events 4 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
4/238 • Number of events 5 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
2.1%
5/240 • Number of events 6 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.2%
3/240 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Nervous system disorders
Headache
|
3.8%
9/238 • Number of events 13 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.83%
2/240 • Number of events 2 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
2.5%
6/240 • Number of events 6 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.42%
1/238 • Number of events 1 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.2%
3/240 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Orophayngeal Pain
|
1.3%
3/238 • Number of events 3 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
0.00%
0/240 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
|
Vascular disorders
Hypertension
|
2.5%
6/238 • Number of events 6 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
1.7%
4/240 • Number of events 4 • Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
|
Additional Information
Keri L. Vaughan
Sr. Director Global Clinical Operations, General Medicine
Phone: +1 267.980.5015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60