Trial Outcomes & Findings for TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk (NCT NCT00179777)
NCT ID: NCT00179777
Last Updated: 2021-07-30
Results Overview
Number of participants with Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age and in the final year of the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5156 participants
Primary outcome timeframe
12 and 18 months and annually from 2 years up to 14 years
Results posted on
2021-07-30
Participant Flow
2002-2007 Recruited through local clinics and obstetrics unit
Participant milestones
| Measure |
Hydrolysed Infant Formula
Hydrolysed infant formula
hydrolysed infant formula: hydrolysed infant formula
|
Nonhydrolysed Infant Formula
Nonhydrolysed infant formula
nonhydrolysed infant formula: nonhydrolysed infant formula
|
|---|---|---|
|
Overall Study
STARTED
|
2613
|
2543
|
|
Overall Study
COMPLETED
|
1081
|
1078
|
|
Overall Study
NOT COMPLETED
|
1532
|
1465
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
Baseline characteristics by cohort
| Measure |
Nonhydrolysed Infant Formula
n=1078 Participants
A conventional adapted cow's milk formula supplemented with 20% of the casein hydrolysate.
|
Hydrolysed Infant Formula
n=1081 Participants
Hydrolysed Infant Formula missing intact cows milk proteins
|
Total
n=2159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1078 Participants
n=5 Participants
|
1081 Participants
n=7 Participants
|
2159 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
At at randomization
|
0 years
n=5 Participants
|
0 years
n=7 Participants
|
0 years
n=5 Participants
|
|
Age, Continuous
Age at Last Follow-up
|
11.96 years
n=5 Participants
|
11.93 years
n=7 Participants
|
11.95 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
516 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
1021 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
562 Participants
n=5 Participants
|
576 Participants
n=7 Participants
|
1138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
987 Participants
n=5 Participants
|
989 Participants
n=7 Participants
|
1976 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1040 Participants
n=5 Participants
|
1034 Participants
n=7 Participants
|
2074 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
196 participants
n=5 Participants
|
199 participants
n=7 Participants
|
395 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
82 participants
n=5 Participants
|
82 participants
n=7 Participants
|
164 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
6 participants
n=5 Participants
|
37 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
262 participants
n=5 Participants
|
265 participants
n=7 Participants
|
527 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
29 participants
n=5 Participants
|
24 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
47 participants
n=5 Participants
|
49 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Region of Enrollment
Luxembourg
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
212 participants
n=5 Participants
|
212 participants
n=7 Participants
|
424 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
57 participants
n=5 Participants
|
55 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
family history of type 1 diabetes
Only mother with type 1 diabetes
|
522 Participants
n=5 Participants
|
530 Participants
n=7 Participants
|
1052 Participants
n=5 Participants
|
|
family history of type 1 diabetes
Only father with type 1 diabetes
|
367 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
722 Participants
n=5 Participants
|
|
family history of type 1 diabetes
Only one sibling with type 1 diabetes
|
157 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
family history of type 1 diabetes
More than one family member with type 1 diabetes
|
32 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 and 18 months and annually from 2 years up to 14 yearsPopulation: Analysis population consisted of participants with increased genetic risk (defined HLA genotypes) for type 1 diabetes
Number of participants with Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age and in the final year of the study.
Outcome measures
| Measure |
Nonhydrolysed Infant Formula
n=1078 Participants
Number of participants diagnosed with type 1 diabetes
|
Hydrolysed Infant Formula
n=1081 Participants
Number of participants diagnosed with type 1 diabetes
|
|---|---|---|
|
Number of Participants With Type 1 Diabetes Mellitus
|
82 participants
|
91 participants
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12, 18 months and annually from 2 years up to 14 yearsPopulation: Analysis population consisted of participants with increased genetic risk (defined HLA genotypes) for type 1 diabetes
Diabetes associated autoantibodies (ICA, IAA, GADA, IA-2A) at 3, 6, 9, 12, and 18 months of age, and annually from age 2 to 10-14 years
Outcome measures
| Measure |
Nonhydrolysed Infant Formula
n=1078 Participants
Number of participants diagnosed with type 1 diabetes
|
Hydrolysed Infant Formula
n=1081 Participants
Number of participants diagnosed with type 1 diabetes
|
|---|---|---|
|
Number of Participants With Diabetes Associated Autoantibodies
ICA+
|
373 Participants
|
394 Participants
|
|
Number of Participants With Diabetes Associated Autoantibodies
IAA+
|
162 Participants
|
183 Participants
|
|
Number of Participants With Diabetes Associated Autoantibodies
GADA+
|
186 Participants
|
207 Participants
|
|
Number of Participants With Diabetes Associated Autoantibodies
IA-2A+
|
102 Participants
|
115 Participants
|
Adverse Events
Nonhydrolysed Infant Formula
Serious events: 379 serious events
Other events: 1010 other events
Deaths: 5 deaths
Hydrolysed Infant Formula
Serious events: 377 serious events
Other events: 1012 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Nonhydrolysed Infant Formula
n=1078 participants at risk
Reported Adverse Events during the Follow-up in the Nonhydrolysed Infant Formula Group
|
Hydrolysed Infant Formula
n=1081 participants at risk
Reported Adverse Events during the Follow-up in the Hydrolysed Infant Formula Group
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
4.7%
51/1078 • Number of events 64 • 11.5 years
|
4.3%
46/1081 • Number of events 56 • 11.5 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.2%
35/1078 • Number of events 46 • 11.5 years
|
2.7%
29/1081 • Number of events 36 • 11.5 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.1%
12/1078 • Number of events 12 • 11.5 years
|
1.0%
11/1081 • Number of events 13 • 11.5 years
|
|
Ear and labyrinth disorders
Middle Ear Infection
|
2.1%
23/1078 • Number of events 24 • 11.5 years
|
2.5%
27/1081 • Number of events 35 • 11.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.1%
12/1078 • Number of events 15 • 11.5 years
|
0.83%
9/1081 • Number of events 9 • 11.5 years
|
|
Infections and infestations
Other Unspecified Infection
|
5.8%
62/1078 • Number of events 64 • 11.5 years
|
5.6%
61/1081 • Number of events 65 • 11.5 years
|
|
Gastrointestinal disorders
Suspected Study Formula Intolerence
|
0.46%
5/1078 • Number of events 5 • 11.5 years
|
0.28%
3/1081 • Number of events 3 • 11.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma, Other Forms of Allergy
|
0.93%
10/1078 • Number of events 14 • 11.5 years
|
1.4%
15/1081 • Number of events 15 • 11.5 years
|
|
General disorders
Malignancy
|
0.09%
1/1078 • Number of events 1 • 11.5 years
|
0.19%
2/1081 • Number of events 2 • 11.5 years
|
|
General disorders
Accident (Not Requiring Hospitalization)
|
0.83%
9/1078 • Number of events 11 • 11.5 years
|
1.0%
11/1081 • Number of events 13 • 11.5 years
|
|
General disorders
Accident (Requiring Hospitalization)
|
2.5%
27/1078 • Number of events 29 • 11.5 years
|
2.1%
23/1081 • Number of events 25 • 11.5 years
|
|
General disorders
Hospitalization
|
4.4%
47/1078 • Number of events 58 • 11.5 years
|
4.8%
52/1081 • Number of events 75 • 11.5 years
|
|
General disorders
Life-threatening event
|
0.37%
4/1078 • Number of events 4 • 11.5 years
|
0.19%
2/1081 • Number of events 2 • 11.5 years
|
|
Injury, poisoning and procedural complications
Disability/incapacity
|
0.28%
3/1078 • Number of events 3 • 11.5 years
|
0.09%
1/1081 • Number of events 2 • 11.5 years
|
|
General disorders
Other Unspecified Adverse Event
|
17.6%
190/1078 • Number of events 268 • 11.5 years
|
19.9%
215/1081 • Number of events 320 • 11.5 years
|
Other adverse events
| Measure |
Nonhydrolysed Infant Formula
n=1078 participants at risk
Reported Adverse Events during the Follow-up in the Nonhydrolysed Infant Formula Group
|
Hydrolysed Infant Formula
n=1081 participants at risk
Reported Adverse Events during the Follow-up in the Hydrolysed Infant Formula Group
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
71.6%
772/1078 • Number of events 6206 • 11.5 years
|
69.8%
754/1081 • Number of events 5952 • 11.5 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
47.8%
515/1078 • Number of events 1519 • 11.5 years
|
45.7%
494/1081 • Number of events 1598 • 11.5 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
8.4%
91/1078 • Number of events 123 • 11.5 years
|
7.4%
80/1081 • Number of events 130 • 11.5 years
|
|
Ear and labyrinth disorders
Middle Ear Infection
|
49.5%
534/1078 • Number of events 1951 • 11.5 years
|
48.6%
525/1081 • Number of events 1796 • 11.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.6%
93/1078 • Number of events 119 • 11.5 years
|
8.4%
91/1081 • Number of events 110 • 11.5 years
|
|
Infections and infestations
Other, unspecified infection
|
71.0%
765/1078 • Number of events 3285 • 11.5 years
|
68.5%
740/1081 • Number of events 3226 • 11.5 years
|
|
Gastrointestinal disorders
Suspected Study Formula Intolerance
|
5.2%
56/1078 • Number of events 73 • 11.5 years
|
4.5%
49/1081 • Number of events 61 • 11.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma, other forms of allergy
|
33.3%
359/1078 • Number of events 783 • 11.5 years
|
30.7%
332/1081 • Number of events 696 • 11.5 years
|
|
Injury, poisoning and procedural complications
Accident, not requiring hospitalization
|
14.0%
151/1078 • Number of events 194 • 11.5 years
|
13.0%
140/1081 • Number of events 189 • 11.5 years
|
|
Endocrine disorders
Hypoglycemia requiring IV glucose
|
1.9%
20/1078 • Number of events 20 • 11.5 years
|
0.93%
10/1081 • Number of events 10 • 11.5 years
|
|
General disorders
Other, unspecified adverse event
|
74.6%
804/1078 • Number of events 4452 • 11.5 years
|
75.3%
814/1081 • Number of events 4380 • 11.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place