Trial Outcomes & Findings for Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy) (NCT NCT03260868)

NCT ID: NCT03260868

Last Updated: 2022-04-07

Results Overview

Change in HbA1c was calculated by subtracting baseline value from Week 24 value.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2022-04-07

Participant Flow

Participants were enrolled in the study at 6 sites in Canada and United States between 19 September 2017 and 02 October 2018.

A total of 15 participants were randomized in study. Randomization was stratified by glycated hemoglobin (HbA1c) (less than [<] 7.6 percent [%] and greater than or equal to [>=] 7.6%) value at screening visit. Assignment in arms was done using interactive response technology (IRT) in 1:1 ratio to either virtual or traditional approach group.

Participant milestones

Measure	Virtual Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Overall Study STARTED	8	7
Overall Study Safety Population	8	6
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Virtual Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Overall Study Poor Compliance to Protocol	0	2
Overall Study Study Terminated By Sponsor	2	1
Overall Study Other than specified above	1	0

Baseline Characteristics

Number analyzed signifies participants evaluable for this baseline measure.

Baseline characteristics by cohort

Measure	Virtual n=8 Participants Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional n=7 Participants Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.	Total n=15 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 5.6 • n=8 Participants	45.6 years STANDARD_DEVIATION 14.3 • n=7 Participants	49.6 years STANDARD_DEVIATION 10.9 • n=15 Participants
Sex: Female, Male Female	2 Participants n=8 Participants	0 Participants n=7 Participants	2 Participants n=15 Participants
Sex: Female, Male Male	6 Participants n=8 Participants	7 Participants n=7 Participants	13 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) White	8 Participants n=8 Participants	7 Participants n=7 Participants	15 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Body mass index (BMI)	38.2 kilogram per meter square (kg/m^2) STANDARD_DEVIATION 18.4 • n=7 Participants • Number analyzed signifies participants evaluable for this baseline measure.	30.9 kilogram per meter square (kg/m^2) STANDARD_DEVIATION 4.1 • n=6 Participants • Number analyzed signifies participants evaluable for this baseline measure.	34.8 kilogram per meter square (kg/m^2) STANDARD_DEVIATION 13.8 • n=13 Participants • Number analyzed signifies participants evaluable for this baseline measure.
Duration of Type 1 Diabetes	32.4 years STANDARD_DEVIATION 11.5 • n=8 Participants	19.3 years STANDARD_DEVIATION 12.7 • n=7 Participants	26.3 years STANDARD_DEVIATION 13.4 • n=15 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Analysis was performed on intent to treat (ITT) population which included all randomized participants, irrespective of the trial approach group actually being used, analyzed according to the approach group allocated by randomization. Here, "overall number of participants analyzed" signifies participants with available data for the outcome measure.

Change in HbA1c was calculated by subtracting baseline value from Week 24 value.

Outcome measures

Measure	Virtual n=5 Participants Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional n=3 Participants Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24	0.10 percentage of HbA1c Standard Deviation 0.76	0.33 percentage of HbA1c Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure.

Change in HbA1c was calculated by subtracting baseline value from Week 16 value.

Outcome measures

Measure	Virtual n=6 Participants Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional n=4 Participants Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Change From Baseline in Glycated Hemoglobin A1c to Week 16	0.23 percentage of HbA1c Standard Deviation 0.52	0.45 percentage of HbA1c Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 24

Population: Analysis was performed on ITT population. Here, "number analyzed" signifies participants with available data for each time point.

Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.

Outcome measures

Measure	Virtual n=8 Participants Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional n=7 Participants Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24 Week 16	-0.660 millimole per liter (mmol/L) Standard Deviation 2.387	-0.200 millimole per liter (mmol/L) Standard Deviation 4.555
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24 Week 24	-3.625 millimole per liter (mmol/L) Standard Deviation 3.406	2.900 millimole per liter (mmol/L) Standard Deviation 1.758

SECONDARY outcome

Timeframe: At Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During 24 weeks treatment period

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) "Never" to 4 = "Always". Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0, Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During 24 weeks treatment period

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During 24 weeks treatment period

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24

Population: Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.

An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During 24 weeks treatment period

Population: Analysis was done on safety population which included all randomized participants who did actually receive at least one dose of investigational medicinal product (IMP), regardless of the amount of IMP administered.

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >3.9 mmol/L (70 mg/dL).

Outcome measures

Measure	Virtual n=8 Participants Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional n=6 Participants Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Asymptomatic hypoglycemia <3.0 mmol/L	1 Participants	1 Participants
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Pseudo-hypoglycemia >3.9 mmol/L	1 Participants	0 Participants
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Any hypoglycemia	7 Participants	3 Participants
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Severe hypoglycemia	0 Participants	0 Participants
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Documented symptomatic hypoglycemia: <=3.9 mmol/L	6 Participants	3 Participants
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Documented symptomatic hypoglycemia: <3.0 mmol/L	4 Participants	3 Participants
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Probable symptomatic hypoglycemia	0 Participants	0 Participants
Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period Asymptomatic hypoglycemia <=3.9 mmol/L	4 Participants	3 Participants

Adverse Events

Virtual

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Traditional

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Virtual n=8 participants at risk Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional n=6 participants at risk Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Gastrointestinal disorders Obstructive Pancreatitis	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	0.00% 0/6 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Hepatobiliary disorders Cholecystitis Acute	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	0.00% 0/6 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Infections and infestations Escherichia Bacteraemia	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	0.00% 0/6 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Nervous system disorders Loss Of Consciousness	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	0.00% 0/6 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.

Other adverse events

Measure	Virtual n=8 participants at risk Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.	Traditional n=6 participants at risk Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
General disorders Oedema Peripheral	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Hepatobiliary disorders Cholelithiasis	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	0.00% 0/6 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Infections and infestations Gastroenteritis Viral	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Infections and infestations Nasopharyngitis	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	33.3% 2/6 • Number of events 2 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Injury, poisoning and procedural complications Alcohol Poisoning	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Injury, poisoning and procedural complications Head Injury	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Investigations Blood Pressure Increased	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	0.00% 0/6 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Vertebral Osteophyte	0.00% 0/8 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	16.7% 1/6 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Vascular disorders Intermittent Claudication	12.5% 1/8 • Number of events 1 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.	0.00% 0/6 • All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product. Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
• Publication restrictions are in place

Restriction type: OTHER