parallel randomized trial

NCT02212067

A Single-centre, Randomised, Double-blind, Multiple-dose, Placebo-controlled, Parallel-group Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT02212067S001486

Design

Randomized: 75
Start year: 2014
Treatment: 12 weeks, follow-up 17 weeks
Countries: Germany (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 64; HbA1c 6.5 to 9.0 percent; BMI 20 to 35; diet and exercise or metformin

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	diet and exercise with or without metformin; lifestyle: not reported	37
A2	Placebo Placebo	diet and exercise with or without metformin; lifestyle: not reported	38

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Placebo A2	Whole trial ALL
age	max (years)	64	64
age	mean (years)	56	57
age	min (years)	45	44
bmi	max (kg/m2)	35.1	35.3
bmi	mean (kg/m2)	29.5	29.7
bmi	min (kg/m2)	20.7	21.9
diabetes duration	max (years)	22.2	21.3
diabetes duration	mean (years)	8.3	8.7
diabetes duration	min (years)	1.0	1.4
hba1c	max (percent)	8.9	9.0
hba1c	mean (percent)	7.3	7.3
hba1c	min (percent)	6.4	5.9
metformin use	n	33	34
metformin use	percent	89.1	89.5
other male	n	27	24
other male	percent	73.0	63.2
weight	max (kg)	119.6	120.0
weight	mean (kg)	93.2	90.0
weight	min (kg)	61.9	64.1
white	percent			100

Analyses this trial contributes to

Results

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

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Detail
12	A1	change	-4.2 kg		not stated; other; R0021892:Results
12	A1 vs A2	md	-4.1 kg	-5.1 to -3.1	not stated; other; R0021892:Results
12	A2	change	-0.1 kg		not stated; other; R0021892:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 37	not stated; randomized; R0021892:Supplement Table 2
	A2	events				0 / 38	not stated; randomized; R0021892:Supplement Table 2

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 38	not stated; randomized; R0021892:Supplement Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 37	not stated; randomized; R0021892:Supplement Table 2
	A2	events				0 / 38	not stated; randomized; R0021892:Supplement Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 37	not stated; randomized; R0021892:Supplement Table 2
	A2	events				0 / 38	not stated; randomized; R0021892:Supplement Table 2

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 37	not stated; randomized; R0021892:Results
	A2	events				2 / 38	not stated; randomized; R0021892:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 37	not stated; randomized; R0021892:Results
	A2	events				2 / 38	not stated; randomized; R0021892:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 37	not stated; randomized; R0021892:Results
	A2	events				3 / 38	not stated; randomized; R0021892:Results

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 38	not stated; randomized; R0021892:Supplement Table 2

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 37	not stated; randomized; R0021892:Supplement Table 2
	A2	events				0 / 38	not stated; randomized; R0021892:Supplement Table 2