LivingGLP1
parallel randomized trial

NCT02960659

Therapeutic Targets in African-American Youth With Type 2 Diabetes

Design

Randomized
24
Start year
2017
Treatment
12 weeks, follow-up 12 weeks
Countries
United States (1 sites)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (non industry)
Eligibility
age 12 to 25 years; HbA1c 9 percent or less; diabetes 5 years or less; Tanner 4 to 5; African American

Conduct and analysis

Blinding
open label
Sequence generation
not reported
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
per protocol
Missing data
none

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Standard care or no added treatment
Metformin
metformin titrated over 3 weeks to 1000 mg twice daily; lifestyle: standard1411
A2Liraglutide 1.8 mg subcutaneous once daily
Metformin and liraglutide
metformin 1000 mg twice daily; lifestyle: standard1110

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticStandard care or no added treatment
A1
Liraglutide 1.8 mg subcutaneous once daily
A2
agemean (years)15.615.0
agesd (years)2.12.1
asiann00
blackn1311
bmimean (kg/m2)39.438.2
bmisd (kg/m2)7.98.0
diabetes durationmean (years)1.51.0
femalen77
femalepercent5064
hba1cmean (percent)6.47.4
hba1csd (percent)0.70.9
other race american indian alaska nativen00
other race multiplen00
other race native hawaiian pacific islandern00
sbpmean (mmHg)131128
sbpsd (mmHg)1414
weightmean (kg)116.2113.3
weightsd (kg)25.323.3
whiten00

Analyses this trial contributes to

Results

12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
12A1final47.1 mmol/mol39.4 to 54.7not stated; per protocol; R0019860:Table 1
12A2final50.0 mmol/mol34.2 to 65.8not stated; per protocol; R0019860:Table 1
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 13not stated; safety; registry:adverse_events
A2events3 / 11not stated; safety; registry:adverse_events
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 13not stated; safety; registry:adverse_events
A2events0 / 11not stated; safety; registry:adverse_events
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 13not stated; safety; registry:adverse_events
A2events1 / 11not stated; safety; registry:adverse_events
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 13not stated; safety; registry:adverse_events
A2events3 / 11not stated; safety; registry:adverse_events
Diarrhea (2 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 13not stated; safety; registry:adverse_events
A2events2 / 11not stated; safety; registry:adverse_events