Trial Outcomes & Findings for Mylan Insulin Glargine Study (NCT NCT03376789)

NCT ID: NCT03376789

Last Updated: 2022-03-03

Results Overview

Change in HbA1c from baseline

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 219 participants
• Primary outcome timeframe: Baseline to Week 18
• Results posted on: 2022-03-03

Participant Flow

Participant milestones

Measure	MYL-1501D (Process V Product) MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Overall Study STARTED	108	111
Overall Study COMPLETED	103	102
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Measure	MYL-1501D (Process V Product) MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Overall Study Withdrawal by Subject	3	5
Overall Study Protocol Violation	0	1
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	1
Overall Study Per sponsor due to noncompliance	1	0
Overall Study Subject off study medication	0	1

Baseline Characteristics

Mylan Insulin Glargine Study

Baseline characteristics by cohort

Measure	MYL-1501D (Process V Product) n=108 Participants MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) n=111 Participants MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI	Total n=219 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 11.46 • n=5 Participants	42.8 years STANDARD_DEVIATION 12.14 • n=7 Participants	42.8 years STANDARD_DEVIATION 11.78 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	76 Participants n=7 Participants	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	98 Participants n=7 Participants	196 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	103 Participants n=7 Participants	198 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Screening Weight (kg)	83.58 kilograms STANDARD_DEVIATION 16.137 • n=5 Participants	82.42 kilograms STANDARD_DEVIATION 14.782 • n=7 Participants	82.99 kilograms STANDARD_DEVIATION 15.441 • n=5 Participants
Screening BMI (kg/m^2)	27.37 kg/m^2 STANDARD_DEVIATION 3.726 • n=5 Participants	27.29 kg/m^2 STANDARD_DEVIATION 3.927 • n=7 Participants	27.33 kg/m^2 STANDARD_DEVIATION 3.821 • n=5 Participants
Duration of diabetes	22.321 years STANDARD_DEVIATION 13.2876 • n=5 Participants	21.736 years STANDARD_DEVIATION 13.3418 • n=7 Participants	22.025 years STANDARD_DEVIATION 13.2878 • n=5 Participants
Time of glargine administration Morning	32 Participants n=5 Participants	37 Participants n=7 Participants	69 Participants n=5 Participants
Time of glargine administration Evening	76 Participants n=5 Participants	74 Participants n=7 Participants	150 Participants n=5 Participants
Baseline FPG	8.793 mmol/L STANDARD_DEVIATION 3.9095 • n=5 Participants	9.065 mmol/L STANDARD_DEVIATION 3.7223 • n=7 Participants	8.931 mmol/L STANDARD_DEVIATION 3.8094 • n=5 Participants
Baseline HbA1c	7.281 % STANDARD_DEVIATION 0.8759 • n=5 Participants	7.371 % STANDARD_DEVIATION 0.8681 • n=7 Participants	7.327 % STANDARD_DEVIATION 0.8711 • n=5 Participants
Insulin use prior to screening Yes	108 Participants n=5 Participants	111 Participants n=7 Participants	219 Participants n=5 Participants
Insulin use prior to screening No	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fasting C-peptide	0.041 mmol/L STANDARD_DEVIATION 0.0430 • n=5 Participants	0.039 mmol/L STANDARD_DEVIATION 0.0533 • n=7 Participants	0.040 mmol/L STANDARD_DEVIATION 0.0484 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 18

Change in HbA1c from baseline

Outcome measures

Measure	MYL-1501D (Process V Product) n=108 Participants MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) n=111 Participants MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Change in HbA1c	0.18 percentage of change Standard Error 0.055	0.15 percentage of change Standard Error 0.053

SECONDARY outcome

Timeframe: Baseline to Week 18

Change in fasting plasma glucose from baseline

Outcome measures

Measure	MYL-1501D (Process V Product) n=108 Participants MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) n=111 Participants MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Change in FPG	0.64 mmol/L Standard Deviation 5.754	0.01 mmol/L Standard Deviation 4.767

SECONDARY outcome

Timeframe: Baseline to Week 18

Change in daily total insulin dose per unit body weight (U/kg) from baseline

Outcome measures

Measure	MYL-1501D (Process V Product) n=108 Participants MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) n=111 Participants MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Change in Insulin Dose	-0.004 Units per kilogram Standard Deviation 0.1039	0.007 Units per kilogram Standard Deviation 0.0884

SECONDARY outcome

Timeframe: Baseline to Week 18

Change in 8-point self-monitored blood glucose (SMBG) daily average

Outcome measures

Measure	MYL-1501D (Process V Product) n=108 Participants MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) n=111 Participants MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Change in 8-point SMBG	0.10 mmol/L Standard Deviation 1.317	0.11 mmol/L Standard Deviation 1.743

Adverse Events

MYL-1501D (Process V Product)

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

MYL-1501D (Process VI Product)

Serious events: 7 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	MYL-1501D (Process V Product) n=108 participants at risk MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) n=110 participants at risk MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Immune system disorders Food allergy	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Laceration	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Hypoglycaemia	2.8% 3/108 • Number of events 4 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	3.6% 4/110 • Number of events 4 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.

Other adverse events

Measure	MYL-1501D (Process V Product) n=108 participants at risk MYL-1501D (Process V Product) MYL-1501D: Process V or Process VI	MYL-1501D (Process VI Product) n=110 participants at risk MYL-1501D (Process VI Product) MYL-1501D: Process V or Process VI
Reproductive system and breast disorders Ovarian cyst	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Diarrhoea	3.7% 4/108 • Number of events 5 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Nausea	0.93% 1/108 • Number of events 5 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	4.5% 5/110 • Number of events 6 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Upper respiratory tract infection	6.5% 7/108 • Number of events 7 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	2.7% 3/110 • Number of events 3 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Nasopharyngitis	3.7% 4/108 • Number of events 4 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	3.6% 4/110 • Number of events 4 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Gastroenteritis	3.7% 4/108 • Number of events 5 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	2.7% 3/110 • Number of events 3 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Gastroenteritis viral	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	3.6% 4/110 • Number of events 4 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Hypoglycaemia	2.8% 3/108 • Number of events 4 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	3.6% 4/110 • Number of events 4 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Cardiac disorders Bundle branch block right	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Cardiac disorders Left atrial enlargement	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Ear and labyrinth disorders Cerumen impaction	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Endocrine disorders Hypothyroidism	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Eye disorders Vitreous haemorrhage	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Vomiting	0.93% 1/108 • Number of events 5 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	4.5% 5/110 • Number of events 6 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Gastrooesophagael reflux disease	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Abdominal pain	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Constipation	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Dyspepsia	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Gastrointestinal disorders Gingival swelling	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
General disorders Chills	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
General disorders Injection site haemorrhage	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
General disorders Injection site rash	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
General disorders Non-cardiac chest pain	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
General disorders Systemic inflammatory response syndrome	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Immune system disorders Food allergy	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Immune system disorders Seasonal allergy	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Respiratory tract infection	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Sinusitis	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Urinary tract infection	1.9% 2/108 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Bronchitis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Cellulitis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Diverticulitis	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Ear infection	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Genital herpes simplex	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Injection site infection	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Onychomycosis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Oral candidiasis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Oral herpes	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Pharyngitis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Pyuria	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Respiratory tract infection viral	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Root canal infection	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Tooth infection	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Infections and infestations Viral respiratory tract infection	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Arthropod bite	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Foot fracture	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Thermal burn	1.9% 2/108 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Contusion	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Joint injury	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Laceration	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Ligament sprain	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Limb injury	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Skin wound	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Injury, poisoning and procedural complications Wound	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Alanine aminotransferase increased	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Aspartate aminotransferase increased	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Weight increased	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Blood creatinine increased	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Blood glucose increased	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Blood potassium increased	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Blood urea increased	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Investigations Weight decreased	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Ketosis	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Dyslipidaemia	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Metabolism and nutrition disorders Increased appetite	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Musculoskeletal and connective tissue disorders Back pain	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Musculoskeletal and connective tissue disorders Pain in extremity	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Musculoskeletal and connective tissue disorders Tendonitis	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 2/108 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Musculoskeletal and connective tissue disorders Flank pain	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Musculoskeletal and connective tissue disorders Muscle spasms	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Nervous system disorders Headache	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Nervous system disorders Dizziness	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Nervous system disorders Migraine	1.9% 2/108 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Nervous system disorders Sinus headache	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Psychiatric disorders Depression	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Psychiatric disorders Insomnia	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Renal and urinary disorders Acute kidney injury	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Renal and urinary disorders Dysuria	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Renal and urinary disorders Renal failure	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Reproductive system and breast disorders Pelvic pain	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.9% 2/108 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Respiratory, thoracic and mediastinal disorders Sneezing	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Skin and subcutaneous tissue disorders Rash	1.9% 2/108 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Skin and subcutaneous tissue disorders Actinic keratosis	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Surgical and medical procedures Vasectomy	0.93% 1/108 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.00% 0/110 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Vascular disorders Hypertension	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	1.8% 2/110 • Number of events 2 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.
Vascular disorders Hypotension	0.00% 0/108 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.	0.91% 1/110 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of the Follow-up visit, an average of 26 weeks. All safety analyses were carried out using the Safety population, which was defined as all subjects who were randomized and received ≥ 1 dose of IP.

Additional Information

Keri L Vaughan

Director Global Clinical Operations, General Medicine

Phone: +1 267.980.5015

Email: keri.vaughan@mylan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60