Trial Outcomes & Findings for Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes (NCT NCT00837759)

NCT ID: NCT00837759

Last Updated: 2013-01-03

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 months following the protocol subject's randomization/treatment initiation
• Results posted on: 2013-01-03

Participant Flow

Participant milestones

Measure	T1D Group Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Overall Study STARTED	7
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	T1D Group Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Overall Study Protocol Violation	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

Baseline characteristics by cohort

Measure	T1D Group n=7 Participants Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	21.9 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months following the protocol subject's randomization/treatment initiation

Population: Only 3 subjects completed study

Outcome measures

Measure	T1D Group n=3 Participants Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Change in C-peptide	0.51 ng/mL Standard Deviation 0.53

SECONDARY outcome

Timeframe: 6 months following the protocol subject's randomization/treatment initiation

Population: Only 3 subjects completed study

Outcome measures

Measure	T1D Group n=3 Participants Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Glycemia Control (Change in HbA1c Level)	-1.17 Percentage Standard Deviation 0.45

SECONDARY outcome

Timeframe: 6 months following the protocol subject's randomization/treatment initiation

Outcome measures

Measure	T1D Group n=3 Participants Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Change in Insulin Dose	0.02 U/kg/day Standard Deviation 0.32

SECONDARY outcome

Timeframe: 6 months following the protocol subject's randomization/treatment initiation

Outcome measures

Measure	T1D Group n=3 Participants Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Change in Anti-GAD Autoantibody Titers	119278 Titers Standard Error 174649

SECONDARY outcome

Timeframe: 6 months following the protocol subject's randomization/treatment initiation

Outcome measures

Measure	T1D Group n=3 Participants Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Change in Anti-IA2 Titer	-29212 Titers Standard Error 49956

SECONDARY outcome

Timeframe: 6 months following the protocol subject's randomization/treatment initiation

Outcome measures

Measure	T1D Group n=3 Participants Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Change in ZnT8 Autoantibody Titer	-0.11 Titers Standard Error 0.19

Adverse Events

T1D Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	T1D Group n=7 participants at risk Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
Metabolism and nutrition disorders Hypoglycemic events	100.0% 3/3 • Number of events 104
General disorders Rhinitis	33.3% 1/3 • Number of events 1
General disorders Eczema	33.3% 1/3 • Number of events 2
General disorders Warts	33.3% 1/3 • Number of events 2
General disorders Thrombocytopenia	33.3% 1/3 • Number of events 1
General disorders Gastroenteritis	33.3% 1/3 • Number of events 2
General disorders Anemia	33.3% 1/3 • Number of events 1

Additional Information

Dr. Rana Malek

NIDDK, National Institutes of Health

Phone: 3015945288

Email: malekr@mail.nih.gov

Results disclosure agreements

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