parallel randomized trial

NCT01452451

A Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 2 Study to Determine the Tolerability, Pharmacokinetics, and Pharmacodynamics of the GLP 1 Agonist HM11260C in Adult Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Type 2 diabetes (adults)NCT01452451S000386

Design

Randomized: 71
Start year: 2011
Treatment: 9 weeks, follow-up 13 weeks
Countries: United States (9 sites)
Sponsor: Hanmi Pharmaceutical (industry)
Eligibility: age 18 to 65; HbA1c 7 to 10 percent; stable metformin 3 months or more

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	efpeglenatide Efpeglenatide 1 mg once weekly	metformin; lifestyle: not reported	9
A2	Efpeglenatide 2 mg subcutaneous once weekly Efpeglenatide 2 mg once weekly	metformin; lifestyle: not reported	9
A3	Efpeglenatide 4 mg subcutaneous once weekly Efpeglenatide 4 mg once weekly	metformin; lifestyle: not reported	9
A4	Placebo Placebo once weekly	metformin; lifestyle: not reported	8
A5	efpeglenatide Efpeglenatide 8 mg once monthly	metformin; lifestyle: not reported	8
A6	efpeglenatide Efpeglenatide 12 mg once monthly	metformin; lifestyle: not reported	9
A7	efpeglenatide Efpeglenatide 16 mg once monthly	metformin; lifestyle: not reported	6
A8	Placebo Placebo once monthly	metformin; lifestyle: not reported	8

Baseline characteristics

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

Characteristic	Statistic	Placebo A4	Placebo A8	Whole trial ALL
age regimen:efpeglenatide_monthly	mean (years)			49.6
age regimen:efpeglenatide_monthly	sd (years)			9.91
age regimen:efpeglenatide_weekly	mean (years)			53.1
age regimen:efpeglenatide_weekly	sd (years)			6.84
age	mean (years)	53.7	52
age	sd (years)	7.63	8.64
black regimen:efpeglenatide_monthly	n			5
black regimen:efpeglenatide_monthly	percent			20.8
black regimen:efpeglenatide_weekly	n			6
black regimen:efpeglenatide_weekly	percent			22.2
black	n	1	3
black	percent	11.1	37.5
bmi regimen:efpeglenatide_monthly	mean (kg/m2)			33.9
bmi regimen:efpeglenatide_monthly	sd (kg/m2)			5.2
bmi regimen:efpeglenatide_weekly	mean (kg/m2)			34.4
bmi regimen:efpeglenatide_weekly	sd (kg/m2)			4.8
bmi	mean (kg/m2)	31.4	36.9
bmi	sd (kg/m2)	3.5	4.9
diabetes duration regimen:efpeglenatide_monthly	max (months)			286
diabetes duration regimen:efpeglenatide_monthly	median (months)			60
diabetes duration regimen:efpeglenatide_monthly	min (months)			9
diabetes duration regimen:efpeglenatide_weekly	max (months)			297
diabetes duration regimen:efpeglenatide_weekly	median (months)			57
diabetes duration regimen:efpeglenatide_weekly	min (months)			4
diabetes duration	max (months)	144	168
diabetes duration	median (months)	56	39
diabetes duration	min (months)	36	4
female regimen:efpeglenatide_monthly	n			7
female regimen:efpeglenatide_monthly	percent			29.2
female regimen:efpeglenatide_weekly	n			16
female regimen:efpeglenatide_weekly	percent			59.3
female	n	3	5
female	percent	33.3	62.5
hba1c regimen:efpeglenatide_monthly	mean (percent)			8.1
hba1c regimen:efpeglenatide_monthly	sd (percent)			1.0
hba1c regimen:efpeglenatide_weekly	mean (percent)			8.3
hba1c regimen:efpeglenatide_weekly	sd (percent)			1.1
hba1c	mean (percent)	8.0	7.9
hba1c	sd (percent)	1.0	1.0
other metformin duration regimen:efpeglenatide_monthly	median (months)			53
other metformin duration regimen:efpeglenatide_weekly	median (months)			27
other metformin duration	median (months)	44	39
weight regimen:efpeglenatide_monthly	mean (kg)			100.7
weight regimen:efpeglenatide_monthly	sd (kg)			19.1
weight regimen:efpeglenatide_weekly	mean (kg)			97.5
weight regimen:efpeglenatide_weekly	sd (kg)			20.6
weight	mean (kg)	88.2	101.6
weight	sd (kg)	9.6	14.5
white regimen:efpeglenatide_monthly	n			19
white regimen:efpeglenatide_monthly	percent			79.2
white regimen:efpeglenatide_weekly	n			21
white regimen:efpeglenatide_weekly	percent			77.8
white	n	8	5
white	percent	88.9	62.5

Results

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

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
8	A3 vs A4	md	-2.63 kg				not stated; full analysis; R0011716:Results
11	A7 vs A8	md	-2.82 kg				not stated; full analysis; R0011716:Results

HbA1c below 7 percent (8 lines; O03)

Week	Arm	Statistic	Estimate	Detail
8	A1	responders	25	not stated; full analysis; R0011716:Figure 3
8	A2	responders	44	not stated; full analysis; R0011716:Figure 3
8	A3	responders	67	not stated; full analysis; R0011716:Figure 3
8	A4	responders	17	not stated; full analysis; R0011716:Figure 3
11	A5	responders	57	not stated; full analysis; R0011716:Figure 3
11	A6	responders	56	not stated; full analysis; R0011716:Figure 3
11	A7	responders	60	not stated; full analysis; R0011716:Figure 3
11	A8	responders	25	not stated; full analysis; R0011716:Figure 3

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

Arm	Statistic	Events / N	Detail
A3	events	1 /	not stated; safety; R0011716:Results
A4	events	0 / 9	not stated; safety; R0011716:Results
A8	events	0 / 8	not stated; safety; R0011716:Results

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
8	A3 vs A4	md	-3.29 percent				not stated; full analysis; R0011716:Results
11	A7 vs A8	md	-3.30 percent				not stated; full analysis; R0011716:Results