Trial Outcomes & Findings for A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes (NCT NCT03224234)
NCT ID: NCT03224234
Last Updated: 2021-01-22
Results Overview
Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
Week 0 through week 24.
Results posted on
2021-01-22
Participant Flow
The study consented 121 participants. The study team realized that changes needed to be done for the protocol to be efficient. The first 28 candidates were consented for "pilot" data, ten of them were screen failures, 18 were randomized. Data on Insulclock device malfunctions were collected, it was planned to improve all issues by the time the main phase of the study started. 93 subjects were consented for the main study, 13 were screen failures, and 80 subjects were randomized.
Participant milestones
| Measure |
Insulclock With Feedback (Group A)
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
|---|---|---|
|
Main Study
STARTED
|
40
|
40
|
|
Main Study
COMPLETED
|
35
|
35
|
|
Main Study
NOT COMPLETED
|
5
|
5
|
|
Pilot
STARTED
|
11
|
7
|
|
Pilot
COMPLETED
|
11
|
7
|
|
Pilot
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Insulclock With Feedback (Group A)
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
|---|---|---|
|
Main Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulclock With Feedback (Group A)
n=40 Participants
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 Participants
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
n=11 Participants
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot:Insulclock Without Feedback (Group B)
n=7 Participants
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Main study phase · Female
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Main study phase · Male
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
11 participants
n=5 Participants
|
7 participants
n=4 Participants
|
98 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 0 through week 24.Population: Data were collected as a part of main phase of the study only.
Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence.
Outcome measures
| Measure |
Insulclock With Feedback (Group A)
n=40 Participants
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 Participants
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Number of Insulin Injection Irregularities.
|
22.22 irregularities
Standard Deviation 25.12
|
23.10 irregularities
Standard Deviation 26.75
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Data were collected as a part the pilot phase. Data on Insulclock device malfunctions were collected, it was planned to improve all issues by the time the main phase of the study started.
Number of participants experiencing Insulclock device malfunctions are reported
Outcome measures
| Measure |
Insulclock With Feedback (Group A)
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
n=11 Participants
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
n=7 Participants
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Insulclock Device Malfunctions
|
—
|
—
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Data were collected as a part of main phase of the study only.
The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change.
Outcome measures
| Measure |
Insulclock With Feedback (Group A)
n=40 Participants
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 Participants
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.
|
15.45 score on a scale
Standard Deviation 3.7
|
15.18 score on a scale
Standard Deviation 3.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: The questionnaire was considered originally for use in the study, but no replies were received in a timely manner from the companies in charge of providing licensing for it. Therefore, data was not collected.
DRQoL is a composite score, consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), and Problem Areas in Diabetes (PAID) questionnaire score. ITEQ includes 7 domains: leisure activities (4 items), psychological barriers (2 items), handling (5 items), diabetes control (6 items), dependence (5 items), weight control (3 items), sleep (2 items); + 1 additional item assigned to assess overall satisfaction with current insulin therapy regimen. The PAID contains 20 items that describe negative emotions related to diabetes commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores are added up and multiplied by 1.25, generating a total score between 0 - 100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Data were collected as a part of main phase of the study only.
HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). Change in mean HbA1cas will be measure and recorded to monitor glycemic control.
Outcome measures
| Measure |
Insulclock With Feedback (Group A)
n=40 Participants
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 Participants
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Change in Mean HbA1c.
|
-0.9 mg/dL
Standard Deviation 2.02
|
-0.73 mg/dL
Standard Deviation 2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 through week 24.Population: Data were collected as a part of main phase of the study only.
Number of episodes of hypoglycemia will be recorded. For this study, symptomatic hypoglycemia is defined as an event with typical symptoms (i.e., sweating, palpitation, and feeling of hunger) with or without confirmation by plasma glucose \<54 mg/dl (3.9 mmol/L).
Outcome measures
| Measure |
Insulclock With Feedback (Group A)
n=40 Participants
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 Participants
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Number of Episodes of Hypoglycemia.
|
29 number of events
|
25 number of events
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 through week 24.Population: Data were collected as a part of main phase of the study only.
Number of episodes of severe hypoglycemia will be recorded.Severe hypoglycemia is defined as episodes necessitating assistance and associated with measured plasma glucose \< 40 mg/dl (2.2 mmol/L), or with prompt recovery after administration of carbohydrates, glucagon, or other resuscitative actions.
Outcome measures
| Measure |
Insulclock With Feedback (Group A)
n=40 Participants
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 Participants
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Number of Episodes of Severe Hypoglycemia.
|
1 number of events
|
1 number of events
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 through week 24.Population: Data were collected as a part of main phase of the study only.
Daily fasting glucose profile averages will be recorded to monitor glycemic control.
Outcome measures
| Measure |
Insulclock With Feedback (Group A)
n=40 Participants
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 Participants
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Change in Daily Fasting Glucose Profile Averages.
|
142.24 mg/dL
Standard Deviation 32
|
146.54 mg/dL
Standard Deviation 39
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 to 5 days prior to randomization, up to 24 weeks.Population: Data was only collected at baseline, but not at other visits, therefore it was not possible to assess any change, and it was excluded from the analysis.
SMBG refers to home blood glucose testing for people with diabetes. 7-point SMBG profile include fasting, before meals, 2 hours after meals, and bedtime.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeks.Population: The questionnaire was considered originally, but no replies were received in a timely manner from the company in charge of providing licensing for it. Therefore, data were not collected.
The DQLCTQ-R is a 57-item scale that comprises 8 dimensions: physical function, energy/fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility, and frequency of symptoms.
Outcome measures
Outcome data not reported
Adverse Events
Insulclock With Feedback (Group A)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Insulclock Without Feedback (Group B)
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Pilot: Insulclock With Feedback (Group A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilot: Insulclock Without Feedback (Group B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulclock With Feedback (Group A)
n=40 participants at risk
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 participants at risk
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
n=11 participants at risk
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
n=7 participants at risk
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Vascular disorders
Stroke
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Infections and infestations
Wound Infection
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Cardiac disorders
Heart Failure Readmission
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 2 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Surgical and medical procedures
Surgical Procedures
|
0.00%
0/40 • 24 weeks
|
5.0%
2/40 • Number of events 2 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
Other adverse events
| Measure |
Insulclock With Feedback (Group A)
n=40 participants at risk
Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
|
Insulclock Without Feedback (Group B)
n=40 participants at risk
Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.
Insulclock without feedback: Not feedback on insulin administration.
|
Pilot: Insulclock With Feedback (Group A)
n=11 participants at risk
Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
Pilot: Insulclock Without Feedback (Group B)
n=7 participants at risk
Participants use the Insulclock, but will not receive feedback on insulin administration.
During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Endocrine disorders
Hyperglycemia
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Gastrointestinal disorders
Nausea and vomiting
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 2 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Gastrointestinal disorders
Epigastric pain
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Endocrine disorders
Hypoglicemia
|
5.0%
2/40 • Number of events 2 • 24 weeks
|
0.00%
0/40 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Toe injury
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest pain of muscular etiology
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
5.0%
2/40 • Number of events 2 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
General disorders
Pain
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
General disorders
Leg swelling
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Injury, poisoning and procedural complications
Non serious work related muscular injury
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
General disorders
Abdominal pain
|
0.00%
0/40 • 24 weeks
|
5.0%
2/40 • Number of events 2 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Cardiac disorders
CHF shortness of breath
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/40 • 24 weeks
|
2.5%
1/40 • Number of events 1 • 24 weeks
|
0.00%
0/11 • 24 weeks
|
0.00%
0/7 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place