parallel randomized trial

NCT02081118

A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin

Type 2 diabetes (adults)NCT02081118S000719

Design

Randomized: 209
Start year: 2014
Treatment: 16 weeks, follow-up 22 weeks
Countries: Germany, Hungary, Spain, South Korea, United States (45 sites)
Sponsor: Hanmi Pharmaceutical (industry)
Eligibility: age 18 to under 75; metformin; HbA1c 7.0 to 10 percent; BMI under 40

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	metformin; lifestyle: not reported	51	49
A2	Efpeglenatide 8 mg injection every 4 weeks Efpeglenatide 8 mg monthly	metformin; lifestyle: not reported		52
A3	Efpeglenatide 12 mg injection every 4 weeks Efpeglenatide 12 mg monthly	metformin; lifestyle: not reported		52
A4	Efpeglenatide 16 mg injection every 4 weeks Efpeglenatide 16 mg monthly	metformin; lifestyle: not reported		52

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Efpeglenatide 8 mg injection every 4 weeks A2	Efpeglenatide 12 mg injection every 4 weeks A3	Efpeglenatide 16 mg injection every 4 weeks A4
age	mean (years)	54.7	56.7	56.0	56.4
age	sd (years)	9.9	8.1	9.5	9.5
asian	percent	2.0	1.9	1.9	1.9
black	percent	10.0	17.3	9.6	9.4
bmi	mean (kg/m2)	32.4	32.1	33.0	30.7
bmi	sd (kg/m2)	4.2	4.7	4.6	4.0
diabetes duration	mean (years)	7.2	9.1	7.4	7.2
diabetes duration	sd (years)	5.3	7.4	6.2	4.6
female	percent	54.0	63.5	46.2	52.8
hba1c	mean (percent)	7.90	7.90	7.62	7.91
hba1c	sd (percent)	0.68	0.76	0.74	0.73
other race other	percent	2.0	1.9	1.9	0
weight	mean (kg)	91.8	92.2	93.1	87.0
weight	sd (kg)	19.2	19.2	15.3	14.8
white	percent	86.0	78.8	86.5	88.7

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	-0.32 percent	0.12		49	not stated; full analysis; R0009733:Table 2
16	A2	change	-0.98 percent	0.12		52	not stated; full analysis; R0009733:Table 2
16	A2 vs A1	md	-0.66 percent		-0.99 to -0.33		not stated; full analysis; R0009733:Table 2
16	A3	change	-0.99 percent	0.12		52	not stated; full analysis; R0009733:Table 2
16	A3 vs A1	md	-0.67 percent		-1.0 to -0.34		not stated; full analysis; R0009733:Table 2
16	A4	change	-1.11 percent	0.12		52	not stated; full analysis; R0009733:Table 2
16	A4 vs A1	md	-0.79 percent		-1.13 to -0.45		not stated; full analysis; R0009733:Table 2

Body weight change in kilograms (diabetes) (7 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	-0.34 kg	0.47		49	not stated; full analysis; R0009733:Table 2
16	A2	change	-1.78 kg	0.47		52	not stated; full analysis; R0009733:Table 2
16	A2 vs A1	md	-1.44 kg		-2.76 to -0.13		not stated; full analysis; R0009733:Table 2
16	A3	change	-3.05 kg	0.47		52	not stated; full analysis; R0009733:Table 2
16	A3 vs A1	md	-2.71 kg		-4.02 to -1.39		not stated; full analysis; R0009733:Table 2
16	A4	change	-2.2 kg	0.49		52	not stated; full analysis; R0009733:Table 2
16	A4 vs A1	md	-1.86 kg		-3.21 to -0.51		not stated; full analysis; R0009733:Table 2

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Events / N	Detail
16	A1	responders	15 / 49	not stated; full analysis; R0009733:Table 2
16	A2	responders	26 / 52	not stated; full analysis; R0009733:Table 2
16	A3	responders	26 / 52	not stated; full analysis; R0009733:Table 2
16	A4	responders	24 / 52	not stated; full analysis; R0009733:Table 2

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; safety; R0009733:Results
A2	events	0 / 52	not stated; safety; R0009733:Results
A3	events	0 / 52	not stated; safety; R0009733:Results
A4	events	0 / 53	not stated; safety; R0009733:Results

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; safety; R0009733:Results
A2	events	0 / 52	not stated; safety; R0009733:Results
A3	events	0 / 52	not stated; safety; R0009733:Results
A4	events	0 / 53	not stated; safety; R0009733:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	2 / 50	not stated; safety; R0009733:Table 3
A2	events	0 / 52	not stated; safety; R0009733:Table 3
A3	events	5 / 52	not stated; safety; R0009733:Table 3
A4	events	3 / 53	not stated; safety; R0009733:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 50	not stated; safety; R0009733:Table 3
A2	events	6 / 52	not stated; safety; R0009733:Table 3
A3	events	7 / 52	not stated; safety; R0009733:Table 3
A4	events	8 / 53	not stated; safety; R0009733:Table 3

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 50	not stated; safety; R0009733:Table 3
A2	events	14 / 52	not stated; safety; R0009733:Table 3
A3	events	24 / 52	not stated; safety; R0009733:Table 3
A4	events	23 / 53	not stated; safety; R0009733:Table 3

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 50	not stated; safety; R0009733:Table 3
A2	events	8 / 52	not stated; safety; R0009733:Table 3
A3	events	13 / 52	not stated; safety; R0009733:Table 3
A4	events	17 / 53	not stated; safety; R0009733:Table 3

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	4 / 50	not stated; safety; R0009733:Table 3
A2	events	9 / 52	not stated; safety; R0009733:Table 3
A3	events	8 / 52	not stated; safety; R0009733:Table 3
A4	events	11 / 53	not stated; safety; R0009733:Table 3

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; safety; R0009733:Results
A2	events	0 / 52	not stated; safety; R0009733:Results
A3	events	0 / 52	not stated; safety; R0009733:Results
A4	events	0 / 53	not stated; safety; R0009733:Results

Any cancer (4 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; safety; R0009733:Table 3
A2	events	0 / 52	not stated; safety; R0009733:Table 3
A3	events	1 / 52	not stated; safety; R0009733:Table 3
A4	events	1 / 53	not stated; safety; R0009733:Table 3