Trial Outcomes & Findings for Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients (NCT NCT02542631)

NCT ID: NCT02542631

Last Updated: 2025-02-04

Results Overview

Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 278 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2025-02-04

Participant Flow

Participant milestones

Measure	Bolus Insulin Patch Experimental Treatment Arm	Insulin Pen Comparator Treatment Arm
Overall Study STARTED	139	139
Overall Study COMPLETED	108	108
Overall Study NOT COMPLETED	31	31

Reasons for withdrawal

Measure	Bolus Insulin Patch Experimental Treatment Arm	Insulin Pen Comparator Treatment Arm
Overall Study Adverse Event	1	1
Overall Study Sponsor Termination	1	0
Overall Study Withdrawal by Subject	11	16
Overall Study Protocol Violation	1	1
Overall Study Physician Decision	6	4
Overall Study Lost to Follow-up	6	5
Overall Study Death	1	2
Overall Study Other	2	1
Overall Study Used Prohibited Medication	2	1

Baseline Characteristics

Intent-to-treat (ITT) population

Baseline characteristics by cohort

Measure	Bolus Insulin Patch n=139 Participants Experimental Treatment Arm	Insulin Pen n=139 Participants Comparator Treatment Arm	Total n=278 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 9.7 • n=5 Participants	60.4 years STANDARD_DEVIATION 7.9 • n=7 Participants	59.2 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	52 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	87 Participants n=7 Participants	168 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	120 Participants n=5 Participants	126 Participants n=7 Participants	246 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
A1C	8.6 A1C % STANDARD_DEVIATION 0.9 • n=5 Participants • Intent-to-treat (ITT) population	8.7 A1C % STANDARD_DEVIATION 1.0 • n=7 Participants • Intent-to-treat (ITT) population	8.7 A1C % STANDARD_DEVIATION 1.0 • n=5 Participants • Intent-to-treat (ITT) population

PRIMARY outcome

Timeframe: 24 weeks

Population: The primary outcome measure analysis used a modified intent-to-treat (mITT) population data set which included all the intent-to-treat (ITT) patients who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the last observation carried forward (LOCF) imputation method was used.

Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy

Outcome measures

Measure	Bolus Insulin Patch n=136 Participants Experimental Treatment Arm	Insulin Pen n=138 Participants Comparator Treatment Arm
Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy	-1.69 A1C % Standard Error 0.08	-1.60 A1C % Standard Error 0.08

SECONDARY outcome

Timeframe: 24 weeks

Population: Modified intent-to-treat (mITT) population data set.

Number of patients with A1C ≤7.0% at week 24

Outcome measures

Measure	Bolus Insulin Patch n=136 Participants Experimental Treatment Arm	Insulin Pen n=138 Participants Comparator Treatment Arm
Number of Patients With A1C ≤7.0% at Week 24	85 Participants	77 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Modified intent-to-treat population data subset.

Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients)

Outcome measures

Measure	Bolus Insulin Patch n=52 Participants Experimental Treatment Arm	Insulin Pen n=49 Participants Comparator Treatment Arm
Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24	26.87 % of glucose values Standard Error 2.33	29.84 % of glucose values Standard Error 2.40

SECONDARY outcome

Timeframe: 44 weeks

Population: Only patients with non-missing baseline and endpoint values were included.

Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy

Outcome measures

Measure	Bolus Insulin Patch n=108 Participants Experimental Treatment Arm	Insulin Pen n=109 Participants Comparator Treatment Arm
Change in A1C From Baseline to Week 44	-1.63 A1C % Standard Error 0.10	-1.63 A1C % Standard Error 0.10

SECONDARY outcome

Timeframe: 44 weeks

Population: Only patients with non-missing baseline and endpoint values were included.

Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy

Outcome measures

Measure	Bolus Insulin Patch n=108 Participants Experimental Treatment Arm	Insulin Pen n=109 Participants Comparator Treatment Arm
Number of Patients With A1C ≤7.0% at Week 44	70 Participants	68 Participants

SECONDARY outcome

Timeframe: 44 weeks

Population: Only patients with non-missing week 24 and week 44 values were included.

Change in A1C from week 24 to week 44 after basal and bolus insulin therapy

Outcome measures

Measure	Bolus Insulin Patch n=108 Participants Experimental Treatment Arm	Insulin Pen n=109 Participants Comparator Treatment Arm
Change in A1C From Week 24 to Week 44	0.12 A1C % Standard Error 0.06	0.07 A1C % Standard Error 0.06

SECONDARY outcome

Timeframe: 44 weeks

Population: Intent to Treat. All patients randomized.

An event requiring the assistance of another person to actively administer carbohydrate (including IV dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

Outcome measures

Measure	Bolus Insulin Patch n=139 Participants Experimental Treatment Arm	Insulin Pen n=139 Participants Comparator Treatment Arm
Number of Participants With Severe Hypoglycemic Event	3 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: Per Protocol. Only patients with non-missing baseline and endpoint values were included.

Change in treatment satisfaction with insulin delivery system from baseline to week 24 was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.

Outcome measures

Measure	Bolus Insulin Patch n=124 Participants Experimental Treatment Arm	Insulin Pen n=117 Participants Comparator Treatment Arm
Change in Treatment Satisfaction From Baseline to Week 24	13.63 units on a scale Standard Error 1.94	4.47 units on a scale Standard Error 2.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: Per Protocol. Only patients with non-missing baseline and endpoint values were included.

Change in Diabetes-Specific Quality of Life (QOL), baseline to week 24. was assessed by self-report on the validated Diabetes Specific Quality of Life Survey. Scale is 0-100. Higher score is better.

Outcome measures

Measure	Bolus Insulin Patch n=124 Participants Experimental Treatment Arm	Insulin Pen n=123 Participants Comparator Treatment Arm
Change in Quality of Life From Baseline to Week 24	2.37 units on a scale Standard Error 1.43	-1.95 units on a scale Standard Error 1.44

Adverse Events

Bolus Insulin Patch

Serious events: 10 serious events

Other events: 100 other events

Deaths: 1 deaths

Insulin Pen

Serious events: 13 serious events

Other events: 99 other events

Deaths: 2 deaths

Serious adverse events

Measure	Bolus Insulin Patch n=139 participants at risk Experimental Treatment Arm	Insulin Pen n=139 participants at risk Comparator Treatment Arm
Cardiac disorders Cardiac disorders	3.6% 5/139 • Number of events 7 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	1.4% 2/139 • Number of events 2 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	1.4% 2/139 • Number of events 2 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	1.4% 2/139 • Number of events 3 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
General disorders General Disorders	1.4% 2/139 • Number of events 3 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	0.00% 0/139 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Infections and infestations Infections and Infestations	0.00% 0/139 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	2.2% 3/139 • Number of events 3 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Nervous system disorders Nervous system disorders	0.72% 1/139 • Number of events 1 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	1.4% 2/139 • Number of events 2 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Vascular disorders Vascular disorders	0.72% 1/139 • Number of events 1 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	1.4% 2/139 • Number of events 2 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified	0.00% 0/139 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	1.4% 2/139 • Number of events 2 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.00% 0/139 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	0.72% 1/139 • Number of events 1 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Gastrointestinal disorders Gastrointestinal disorders	0.72% 1/139 • Number of events 1 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	0.00% 0/139 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.00% 0/139 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	0.72% 1/139 • Number of events 1 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.

Other adverse events

Measure	Bolus Insulin Patch n=139 participants at risk Experimental Treatment Arm	Insulin Pen n=139 participants at risk Comparator Treatment Arm
General disorders General disorders	20.1% 28/139 • Number of events 39 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	10.8% 15/139 • Number of events 15 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, and mediastinal disorders	10.1% 14/139 • Number of events 18 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	12.2% 17/139 • Number of events 22 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Nervous system disorders Nervous system disorders	9.4% 13/139 • Number of events 15 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	11.5% 16/139 • Number of events 19 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Investigations Investigations	7.2% 10/139 • Number of events 10 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	10.1% 14/139 • Number of events 14 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Vascular disorders Vascular disorders	8.6% 12/139 • Number of events 12 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	5.8% 8/139 • Number of events 9 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Infections and infestations Infections and infestations	36.7% 51/139 • Number of events 84 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	43.2% 60/139 • Number of events 85 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue	24.5% 34/139 • Number of events 48 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	23.0% 32/139 • Number of events 42 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
Gastrointestinal disorders Gastrointestinal disorders	16.5% 23/139 • Number of events 37 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.	15.1% 21/139 • Number of events 31 • 44 weeks A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.

Additional Information

Brian Levy, MD-Chief Medical Officer

Johnson & Johnson Diabetes Companies

Phone: 484 328-6128

Email: BLevy1@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60