Trial Outcomes & Findings for An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes (NCT NCT01400971)

Last Updated: 2020-03-09

Results Overview

Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Discrimination domain of the Interpersonal Processes of Care Survey \[IPC\] ranges from 1-5 with higher scores indicating more discrimination and Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.

Recruitment status

COMPLETED

Target enrollment

4299 participants

Primary outcome timeframe

Baseline through 24 months

Results posted on

2020-03-09

Participant Flow

Participants who had complete treatment data are participants with complete insulin, oral antidiabetic medication (OAM), and glucagon-like peptide (GLP) data at all 5 visits.

Participant milestones

Participant milestones
Measure	MOSAIc Participants Participants enrolled in Multinational Observational Study Assessing Insulin use (MOSAIc) who had complete treatment data during the study.
Overall Study STARTED	4299
Overall Study Complete Treatment Data	2528
Overall Study COMPLETED	3382
Overall Study NOT COMPLETED	917

Reasons for withdrawal

Reasons for withdrawal
Measure	MOSAIc Participants Participants enrolled in Multinational Observational Study Assessing Insulin use (MOSAIc) who had complete treatment data during the study.
Overall Study Death	82
Overall Study Lost to Follow-up	196
Overall Study Lost to follow up + Subject Decision	2
Overall Study Physician Decision	57
Overall Study Withdrawal by Subject	158
Overall Study Other	422

Baseline Characteristics

An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MOSAIc Participants n=2528 Participants Participants enrolled in MOSAIc who had complete treatment data during the study.
Age, Continuous	61 years STANDARD_DEVIATION 10.8 • n=113 Participants
Sex: Female, Male Female	1270 Participants n=113 Participants
Sex: Female, Male Male	1258 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	497 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1133 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	898 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	35 Participants n=113 Participants
Race (NIH/OMB) Asian	1029 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	78 Participants n=113 Participants
Race (NIH/OMB) Black or African American	71 Participants n=113 Participants
Race (NIH/OMB) White	1272 Participants n=113 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	43 Participants n=113 Participants
Region of Enrollment Puerto Rico	96 Participants n=113 Participants
Region of Enrollment Argentina	101 Participants n=113 Participants
Region of Enrollment Russia	158 Participants n=113 Participants
Region of Enrollment United States	182 Participants n=113 Participants
Region of Enrollment Japan	99 Participants n=113 Participants
Region of Enrollment United Kingdom	24 Participants n=113 Participants
Region of Enrollment United Arab Emirates	48 Participants n=113 Participants
Region of Enrollment India	631 Participants n=113 Participants
Region of Enrollment Spain	108 Participants n=113 Participants
Region of Enrollment Saudi Arabia	148 Participants n=113 Participants
Region of Enrollment Canada	107 Participants n=113 Participants
Region of Enrollment Turkey	100 Participants n=113 Participants
Region of Enrollment China	225 Participants n=113 Participants
Region of Enrollment Brazil	78 Participants n=113 Participants
Region of Enrollment South Korea	83 Participants n=113 Participants
Region of Enrollment Italy	77 Participants n=113 Participants
Region of Enrollment Mexico	126 Participants n=113 Participants
Region of Enrollment Israel	36 Participants n=113 Participants
Region of Enrollment Germany	101 Participants n=113 Participants

PRIMARY outcome

Timeframe: Baseline through 24 months

Population: All participants enrolled in MOSAIc who had complete treatment data during the study.

Outcome measures

Outcome measures
Measure	MOSAIc Participants n=2528 Participants Participants enrolled in MOSAIc who had complete treatment data during the study.
Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy	2171 Participants

SECONDARY outcome

Timeframe: Baseline through 24 months

Population: All participants enrolled in MOSAIc who had complete treatment data during the study.

Hypoglycemia and severe hypoglycemia episodes are self-reported by all participants with complete treatment data from one month prior to the baseline visit until the last visit (24 months). Patients were asked at each visit to self-report any hypoglycemia since their last visit. At the baseline visit participants were asked their hypoglycemia information for the month prior to the baseline visit.

Outcome measures

Outcome measures
Measure	MOSAIc Participants n=2528 Participants Participants enrolled in MOSAIc who had complete treatment data during the study.
Number of Hypoglycemic and Severe Hypoglycemic Episodes Total hypoglycemic episodes during study	7950 episodes
Number of Hypoglycemic and Severe Hypoglycemic Episodes Total severe hypoglycemic episodes during study	225 episodes

SECONDARY outcome

Timeframe: Baseline through 24 months

Population: All participants enrolled in MOSAIc who had complete treatment data during the study.

MOSAIC participants answered the question: "How often did you miss your insulin shots during the last 7 days?". At each visit, participants were defined as visit adherent if the participant answered "I did not miss any shots" or "I missed some of my shots". They were defined as not visit adherent if he/she answered any of the following: "I missed about half of my shots", "I missed most of my shots", or "I missed all of my shots". A participant is defined to be study adherent if at least: 4 out of 5 visit adherent.

Outcome measures

Outcome measures
Measure	MOSAIc Participants n=2528 Participants Participants enrolled in MOSAIc who had complete treatment data during the study.
Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent)	2446 Participants

SECONDARY outcome

Timeframe: Baseline through 24 months

Population: All participants enrolled in MOSAIc who had complete treatment data during the study.

As diabetes management practices vary across the countries represented in MOSAIC, a more apt measure of reaching goal is the personalized target that was set for each patient at the beginning of the study.

Outcome measures

Outcome measures
Measure	MOSAIc Participants n=2528 Participants Participants enrolled in MOSAIc who had complete treatment data during the study.
Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study	392 Participants

Adverse Events

MOSAIc Participants

Serious events: 130 serious events

Other events: 1199 other events

Deaths: 82 deaths

Serious adverse events

Serious adverse events
Measure	MOSAIc Participants n=2528 participants at risk Participants enrolled in MOSAIc who had complete treatment data during the study.
Endocrine disorders Severe Hypoglycemia	5.1% 130/2528 • Number of events 225 • Baseline Through Up To 24 Months Mortality events are reported for all enrolled participants and adverse events are reported for all participants enrolled in MOSAIc who had complete treatment data during the study. Serious adverse events or other (not including serious) adverse events are patient self-reported severe hypos and hypos.

Other adverse events

Other adverse events
Measure	MOSAIc Participants n=2528 participants at risk Participants enrolled in MOSAIc who had complete treatment data during the study.
Endocrine disorders Hypoglycemia	47.4% 1199/2528 • Number of events 7950 • Baseline Through Up To 24 Months Mortality events are reported for all enrolled participants and adverse events are reported for all participants enrolled in MOSAIc who had complete treatment data during the study. Serious adverse events or other (not including serious) adverse events are patient self-reported severe hypos and hypos.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60