Trial Outcomes & Findings for Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2) (NCT NCT02227875)
NCT ID: NCT02227875
Last Updated: 2022-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
560 participants
Primary outcome timeframe
24 weeks
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
Mylan's Insulin Glargine
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Overall Study
STARTED
|
277
|
283
|
|
Overall Study
COMPLETED
|
240
|
250
|
|
Overall Study
NOT COMPLETED
|
37
|
33
|
Reasons for withdrawal
| Measure |
Mylan's Insulin Glargine
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
10
|
7
|
|
Overall Study
Other
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
13
|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
Baseline Characteristics
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)
Baseline characteristics by cohort
| Measure |
Mylan's Insulin Glargine
n=277 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=283 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
Total
n=560 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
|
267 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
534 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
225 participants
n=5 Participants
|
228 participants
n=7 Participants
|
453 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Jordan
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent-to-Treat Population
Outcome measures
| Measure |
Mylan's Insulin Glargine
n=274 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=278 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Change in HbA1c From Baseline to 24 Weeks
|
-0.6 percent
Interval -0.779 to -0.414
|
-0.66 percent
Interval -0.837 to -0.475
|
SECONDARY outcome
Timeframe: Baseline and up to 24 weeksPopulation: Safety Population
The change from baseline at 12 and 24 weeks is reported
Outcome measures
| Measure |
Mylan's Insulin Glargine
n=276 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Rate of Hypoglycemic Events Per 30 Days
week 12
|
0.341 Episodes/30 Days
Standard Deviation 1.8963
|
0.24 Episodes/30 Days
Standard Deviation 2.0551
|
|
Rate of Hypoglycemic Events Per 30 Days
week 24
|
-0.057 Episodes/30 Days
Standard Deviation 0.919
|
-0.102 Episodes/30 Days
Standard Deviation 1.6791
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety Population
Overall hypoglycemic incidence during treatment period
Outcome measures
| Measure |
Mylan's Insulin Glargine
n=276 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Hypoglycemia Occurrence
Any hypoglycemic event
|
130 number of events
|
136 number of events
|
|
Hypoglycemia Occurrence
Severe Hypoglycemia
|
0 number of events
|
1 number of events
|
|
Hypoglycemia Occurrence
Documented Symptomatic Hypoglycemia
|
75 number of events
|
76 number of events
|
|
Hypoglycemia Occurrence
Asymptomatic Hypoglycemia
|
85 number of events
|
92 number of events
|
|
Hypoglycemia Occurrence
Probable Symptomatic Hypoglycemia
|
7 number of events
|
4 number of events
|
|
Hypoglycemia Occurrence
Relative Hypoglycemia
|
20 number of events
|
11 number of events
|
|
Hypoglycemia Occurrence
Unknown
|
29 number of events
|
25 number of events
|
SECONDARY outcome
Timeframe: Week 12 and week 24Population: Safety Population
Comparison of change from Baseline in Immunogenicity
Outcome measures
| Measure |
Mylan's Insulin Glargine
n=276 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
week 12
|
1.9238 percentage of specific binding (SB)
Standard Deviation 12.54369
|
0.6585 percentage of specific binding (SB)
Standard Deviation 8.05473
|
|
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
week 24
|
1.7802 percentage of specific binding (SB)
Standard Deviation 9.64745
|
0.7838 percentage of specific binding (SB)
Standard Deviation 8.15086
|
SECONDARY outcome
Timeframe: week 12 and week 24Population: Safety Population
Comparison of change from Baseline in Immunogenicity
Outcome measures
| Measure |
Mylan's Insulin Glargine
n=276 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
week 12
|
1.787 percentage of SB
Standard Deviation 11.67578
|
0.6462 percentage of SB
Standard Deviation 7.56375
|
|
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
week 24
|
1.6866 percentage of SB
Standard Deviation 9.57132
|
0.8212 percentage of SB
Standard Deviation 8.1084
|
SECONDARY outcome
Timeframe: week 12 and week 24Population: Safety Population
Comparison of change from Baseline in Immunogenicity
Outcome measures
| Measure |
Mylan's Insulin Glargine
n=276 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
week 12
|
1.7488 percentage of SB
Standard Deviation 11.68129
|
0.5116 percentage of SB
Standard Deviation 7.25175
|
|
Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
week 24
|
1.6301 percentage of SB
Standard Deviation 9.11098
|
0.7524 percentage of SB
Standard Deviation 7.93317
|
SECONDARY outcome
Timeframe: Week 12 and week 24Population: Safety Population
Comparison of change from Baseline in Immunogenicity
Outcome measures
| Measure |
Mylan's Insulin Glargine
n=276 Participants
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 Participants
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
week 12
|
1.5994 percentage of SB
Standard Deviation 10.64782
|
0.5014 percentage of SB
Standard Deviation 6.72058
|
|
Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
week 24
|
1.5648 percentage of SB
Standard Deviation 9.04243
|
0.8361 percentage of SB
Standard Deviation 7.96308
|
Adverse Events
Mylan's Insulin Glargine
Serious events: 8 serious events
Other events: 177 other events
Deaths: 0 deaths
Lantus®
Serious events: 9 serious events
Other events: 164 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mylan's Insulin Glargine
n=276 participants at risk
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 participants at risk
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Investigations
Helicobacter test positive
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 2 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Eye disorders
Eye haemorrhage
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/276 • 24 weeks
|
0.71%
2/282 • Number of events 2 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperosmolar hyperglycaemic state
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 2 • 24 weeks
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Bronchitis
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/276 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Paraspinal abscess
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
Other adverse events
| Measure |
Mylan's Insulin Glargine
n=276 participants at risk
receive Mylan's insulin Glargine
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
|
Lantus®
n=282 participants at risk
receive Lantus®
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
2.2%
6/276 • Number of events 6 • 24 weeks
|
0.71%
2/282 • Number of events 2 • 24 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
1.4%
4/282 • Number of events 4 • 24 weeks
|
|
General disorders
Fatigue
|
1.4%
4/276 • Number of events 4 • 24 weeks
|
0.71%
2/282 • Number of events 2 • 24 weeks
|
|
General disorders
Injection site pain
|
1.1%
3/276 • Number of events 4 • 24 weeks
|
0.71%
2/282 • Number of events 3 • 24 weeks
|
|
General disorders
Oedema peripheral
|
0.72%
2/276 • Number of events 2 • 24 weeks
|
2.1%
6/282 • Number of events 6 • 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
1.4%
4/282 • Number of events 4 • 24 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/276 • 24 weeks
|
1.4%
4/282 • Number of events 4 • 24 weeks
|
|
Investigations
Lipase increased
|
1.4%
4/276 • Number of events 4 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
5/276 • Number of events 5 • 24 weeks
|
1.8%
5/282 • Number of events 5 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
4/276 • Number of events 4 • 24 weeks
|
3.5%
10/282 • Number of events 10 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.1%
3/276 • Number of events 3 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Nervous system disorders
Headache
|
2.9%
8/276 • Number of events 9 • 24 weeks
|
3.5%
10/282 • Number of events 11 • 24 weeks
|
|
Nervous system disorders
Tremor
|
2.2%
6/276 • Number of events 9 • 24 weeks
|
0.35%
1/282 • Number of events 3 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
1.4%
4/276 • Number of events 4 • 24 weeks
|
2.5%
7/282 • Number of events 8 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.2%
6/276 • Number of events 6 • 24 weeks
|
1.4%
4/282 • Number of events 4 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
5/276 • Number of events 5 • 24 weeks
|
1.8%
5/282 • Number of events 5 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
4/276 • Number of events 4 • 24 weeks
|
1.8%
5/282 • Number of events 10 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
4/276 • Number of events 4 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.1%
3/276 • Number of events 5 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
3/276 • Number of events 3 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
1.1%
3/282 • Number of events 3 • 24 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.1%
3/276 • Number of events 3 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/276 • 24 weeks
|
1.1%
3/282 • Number of events 3 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.72%
2/276 • Number of events 3 • 24 weeks
|
1.1%
3/282 • Number of events 3 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.36%
1/276 • Number of events 1 • 24 weeks
|
1.1%
3/282 • Number of events 3 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
7/276 • Number of events 7 • 24 weeks
|
2.1%
6/282 • Number of events 6 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
5/276 • Number of events 5 • 24 weeks
|
1.4%
4/282 • Number of events 4 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
4/276 • Number of events 4 • 24 weeks
|
1.8%
5/282 • Number of events 7 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.72%
2/276 • Number of events 2 • 24 weeks
|
1.8%
5/282 • Number of events 5 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
27.2%
75/276 • Number of events 330 • 24 weeks
|
23.4%
66/282 • Number of events 282 • 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
17/276 • Number of events 19 • 24 weeks
|
5.3%
15/282 • Number of events 15 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.3%
12/276 • Number of events 13 • 24 weeks
|
2.8%
8/282 • Number of events 8 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
10/276 • Number of events 11 • 24 weeks
|
4.6%
13/282 • Number of events 14 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
2.9%
8/276 • Number of events 9 • 24 weeks
|
1.4%
4/282 • Number of events 5 • 24 weeks
|
|
Infections and infestations
Influenza
|
2.2%
6/276 • Number of events 7 • 24 weeks
|
1.1%
3/282 • Number of events 3 • 24 weeks
|
|
Infections and infestations
Bronchitis
|
1.8%
5/276 • Number of events 5 • 24 weeks
|
2.5%
7/282 • Number of events 7 • 24 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.8%
5/276 • Number of events 5 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Pharyngitis
|
1.1%
3/276 • Number of events 3 • 24 weeks
|
0.35%
1/282 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
1.1%
3/276 • Number of events 3 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.1%
3/276 • Number of events 3 • 24 weeks
|
0.00%
0/282 • 24 weeks
|
Additional Information
Keri L. Vaughan, Director Global Clinical Operations, General Medicine
Mylan, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60