parallel randomized trial

NCT00754988

A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

Type 2 diabetes (adults)NCT00754988S000027

Design

Randomized: 666
Start year: 2008
Treatment: 156 weeks, follow-up 156 weeks
Countries: multinational (149 sites)
Sponsor: F. Hoffmann-La Roche (industry)
Eligibility: age 18 to 75; HbA1c 7.0 to 10.0 percent; BMI 25 (23 Asian) to 45; metformin at least 1500 mg

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	metformin at least 1500 mg per day; lifestyle: none	93	90
A2	Taspoglutide 10 mg subcutaneous once weekly Taspoglutide 10 mg QW	metformin at least 1500 mg per day; lifestyle: none	190	182
A3	Taspoglutide 20 mg subcutaneous once weekly Taspoglutide 20 mg QW	metformin at least 1500 mg per day; lifestyle: none	198	187
A4	Sitagliptin Sitagliptin 100 mg QD	metformin at least 1500 mg per day; lifestyle: none	185	177

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Taspoglutide 10 mg subcutaneous once weekly A2	Taspoglutide 20 mg subcutaneous once weekly A3	Sitagliptin A4
age	mean (years)	56.1	55.3	56.8	55.5
age	sd (years)	10.1	9.5	8.8	9.9
asian	n	9	15	14	19
asian	percent	10	8	7	11
black	n	5	13	8	10
black	percent	6	7	4	6
bmi	mean (kg/m2)	32.5	32.7	32.3	32.4
bmi	sd (kg/m2)	5.5	5.2	5.0	5.0
diabetes duration	mean (years)	5.5	6.1	5.7	6.0
diabetes duration	sd (years)	3.9	4.8	4.7	5.0
female	n	43	80	89	72
female	percent	48	44	48	41
hba1c	mean (percent)	8.03	7.95	7.97	7.94
hba1c	sd (percent)	0.83	0.93	0.86	0.85
hispanic	n	10	32	35	29
hispanic	percent	11	18	19	16
other fpg	mean (mmol/L)	9.66	9.74	9.64	9.4
other fpg	sd (mmol/L)	2.6	2.48	2.68	2.5
other race other	n	7	11	12	13
other race other	percent	8	6	6	7
sbp	mean (mmHg)	132.3	131.9	133.2	131.7
sbp	se (mmHg)	1.4	1.0	1.0	1.0
weight	mean (kg)	91.1	93.6	91.8	92.5
weight	sd (kg)	19.0	20.4	18.0	19.7
white	n	69	143	153	135
white	percent	77	79	82	76

Analyses this trial contributes to

Results

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

HbA1c change (11 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.10 percent	0.08		90	not stated; modified itt; R0022521:Abstract
24	A2	change	-1.23 percent	0.06		182	not stated; modified itt; R0022521:Results
24	A2 vs A1	md	-1.13 percent		-1.31 to -0.95		not stated; modified itt; R0022521:Results
24	A2 vs A4	md	-0.34 percent		-0.49 to -0.19		not stated; modified itt; R0022521:Results
24	A3	change	-1.30 percent	0.06		187	not stated; modified itt; R0022521:Results
24	A3 vs A1	md	-1.20 percent		-1.38 to -1.02		not stated; modified itt; R0022521:Results
24	A3 vs A4	md	-0.41 percent		-0.56 to -0.26		not stated; modified itt; R0022521:Results
24	A4	change	-0.89 percent	0.06		177	not stated; modified itt; R0022521:Results
52	A2	change	-1.03 percent		-1.15 to -0.91	182	not stated; modified itt; R0022521:Results
52	A3	change	-1.18 percent		-1.30 to -1.06	187	not stated; modified itt; R0022521:Results
52	A4	change	-0.66 percent		-0.78 to -0.54	177	not stated; modified itt; R0022521:Results

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-0.5 kg	0.4	90	not stated; modified itt; R0022521:Results
24	A2	change	-1.8 kg	0.3	182	not stated; modified itt; R0022521:Results
24	A3	change	-2.6 kg	0.3	187	not stated; modified itt; R0022521:Results
24	A4	change	-0.9 kg	0.3	177	not stated; modified itt; R0022521:Results
52	A2	change	-1.6 kg	0.3	182	not stated; modified itt; R0022521:Results
52	A3	change	-2.4 kg	0.3	187	not stated; modified itt; R0022521:Results
52	A4	change	-0.5 kg	0.3	177	not stated; modified itt; R0022521:Results

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
52	A2	responders	57.7	182	not stated; modified itt; R0022521:Results
52	A3	responders	67.9	187	not stated; modified itt; R0022521:Results
52	A4	responders	47.5	177	not stated; modified itt; R0022521:Results

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A2	events	21 / 187	not stated; safety; R0022521:Table 2
A2	events	0 / 187	not stated; safety; R0022521:Abstract
A3	events	0 / 192	not stated; safety; R0022521:Abstract
A3	events	15 / 192	not stated; safety; R0022521:Table 2
A4	events	0 / 184	not stated; safety; R0022521:Abstract
A4	events	18 / 184	not stated; safety; R0022521:Table 2

Systolic blood pressure change (7 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	change	-0.9 mmHg	-3.44 to 1.57	90	not stated; modified itt; R0022521:Table 5
24	A2	change	-4.0 mmHg	-5.84 to -2.25	182	not stated; modified itt; R0022521:Table 5
24	A3	change	-3.3 mmHg	-5.09 to -1.54	187	not stated; modified itt; R0022521:Table 5
24	A4	change	-2.8 mmHg	-4.66 to -1.02	177	not stated; modified itt; R0022521:Table 5
52	A2	change	-2.8 mmHg	-4.65 to -0.89	182	not stated; modified itt; R0022521:Table 5
52	A3	change	-2.7 mmHg	-4.56 to -0.83	187	not stated; modified itt; R0022521:Table 5
52	A4	change	-1.7 mmHg	-3.56 to 0.25	177	not stated; modified itt; R0022521:Table 5

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A2	events	1 / 187	not stated; safety; R0022521:Table 2
A3	events	0 / 192	not stated; safety; R0022521:Table 2
A4	events	0 / 184	not stated; safety; R0022521:Table 2

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A2	events	18 / 187	not stated; safety; R0022521:Table 2
A3	events	18 / 192	not stated; safety; R0022521:Table 2
A4	events	19 / 184	not stated; safety; R0022521:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A2	events	53 / 187	not stated; safety; R0022521:Table 2
A3	events	69 / 192	not stated; safety; R0022521:Table 2
A4	events	13 / 184	not stated; safety; R0022521:Table 2

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A2	events	96 / 187	not stated; safety; R0022521:Table 2
A3	events	111 / 192	not stated; safety; R0022521:Table 2
A4	events	32 / 184	not stated; safety; R0022521:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A2	events	55 / 187	not stated; safety; R0022521:Table 2
A3	events	77 / 192	not stated; safety; R0022521:Table 2
A4	events	12 / 184	not stated; safety; R0022521:Table 2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A2	events	32 / 187	not stated; safety; R0022521:Table 2
A3	events	29 / 192	not stated; safety; R0022521:Table 2
A4	events	10 / 184	not stated; safety; R0022521:Table 2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A2	events	9 / 187	not stated; safety; R0022521:Table 2
A3	events	15 / 192	not stated; safety; R0022521:Table 2
A4	events	3 / 184	not stated; safety; R0022521:Table 2

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A2	events	34 / 187	not stated; safety; R0022521:Table 2
A3	events	39 / 192	not stated; safety; R0022521:Table 2
A4	events	3 / 184	not stated; safety; R0022521:Table 2

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A2	events	0 / 187	not stated; safety; R0022521:Results
A3	events	0 / 192	not stated; safety; R0022521:Results
A4	events	0 / 184	not stated; safety; R0022521:Results