parallel randomized trial

NCT02059564

A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT02059564S001369

Design

Randomized: 47
Start year: 2013
Treatment: 13 weeks, follow-up 18 weeks
Countries: USA (1 sites)
Sponsor: Hanmi Pharmaceutical (industry)
Eligibility: age 18 to 70; HbA1c 6.5 to 10 percent; BMI 18 to 45; metformin with or without sulfonylurea

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized
A1	Efpeglenatide 6 mg subcutaneous once weekly Efpeglenatide 6 mg QW (cohort A)	metformin; lifestyle: not reported	13
A2	Placebo Placebo (cohort A)	metformin; lifestyle: not reported	4
A3	Efpeglenatide 16 mg injection monthly Efpeglenatide 16 mg QM (cohort B)	metformin; lifestyle: not reported	13
A4	Placebo Placebo (cohort B)	metformin; lifestyle: not reported	4
A5	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg QD (cohort C)	metformin; lifestyle: not reported	13

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Efpeglenatide 6 mg subcutaneous once weekly A1	Placebo A2	Efpeglenatide 16 mg injection monthly A3	Placebo A4	Liraglutide 1.8 mg subcutaneous once daily A5
age	mean (years)	52.8	51.3	50.1	56.8	54.9
age	sd (years)	6.09	5.44	11.68	5.38	9.58
bmi	mean (kg/m2)	34.28	30.33	31.59	28.93	29.40
bmi	sd (kg/m2)	4.269	3.974	5.981	3.132	5.132
female	n	4	1	7	2	6
female	percent	30.8	25	53.8	50	46.2
hba1c	mean (percent)	8.38	9.28	8.11	7.93	8.02
hba1c	sd (percent)	1.125	0.369	1.135	1.218	0.727
weight	mean (kg)	98.58	87.98	84.48	77.45	81.71
weight	sd (kg)	15.714	20.025	17.567	7.539	17.413

Analyses this trial contributes to

Results

34 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	Detail
3.14	A5	change	-0.78 percent	not stated; modified itt; R0008346:Results
3.29	A1	change	-1.12 percent	not stated; modified itt; R0008346:Results
3.29	A1 vs A2	md	-0.77 percent	not stated; modified itt; R0008346:Results
12.57	A3	change	-1.61 percent	not stated; modified itt; R0008346:Results
12.57	A3 vs A4	md	-1.26 percent	not stated; modified itt; R0008346:Results

Level 2 or 3 hypoglycemia (participants) (3 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	7 / 13	not stated; safety; R0008346:Table 2
A3	events	5 / 13	not stated; safety; R0008346:Table 2
A5	events	1 / 13	not stated; safety; R0008346:Table 2

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 13	not stated; safety; R0008346:Results
A2	events	0 / 4	not stated; safety; R0008346:Results
A3	events	0 / 13	not stated; safety; R0008346:Results
A4	events	0 / 4	not stated; safety; R0008346:Results
A5	events	0 / 13	not stated; safety; R0008346:Results

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 13	not stated; safety; R0008346:Results
A2	events	0 / 4	not stated; safety; R0008346:Results
A3	events	1 / 13	not stated; safety; R0008346:Results
A4	events	0 / 4	not stated; safety; R0008346:Results
A5	events	0 / 13	not stated; safety; R0008346:Results

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	5 / 13	not stated; safety; R0008346:Table 2
A3	events	8 / 13	not stated; safety; R0008346:Table 2
A4	events	1 / 4	not stated; safety; R0008346:Table 2
A5	events	4 / 13	not stated; safety; R0008346:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	3 / 13	not stated; safety; R0008346:Table 2
A3	events	6 / 13	not stated; safety; R0008346:Table 2
A5	events	2 / 13	not stated; safety; R0008346:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	5 / 13	not stated; safety; R0008346:Table 2
A2	events	1 / 4	not stated; safety; R0008346:Table 2
A3	events	7 / 13	not stated; safety; R0008346:Table 2
A5	events	2 / 13	not stated; safety; R0008346:Table 2

Discontinuation due to gastrointestinal adverse events (5 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 13	not stated; safety; R0008346:Results
A2	events	0 / 4	not stated; safety; R0008346:Results
A3	events	1 / 13	not stated; safety; R0008346:Results
A4	events	0 / 4	not stated; safety; R0008346:Results
A5	events	0 / 13	not stated; safety; R0008346:Results