parallel randomized trial

NCT00717457

Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT00717457S000414

Design

Randomized: 1,189
Start year: 2008
Treatment: 52 weeks, follow-up 104 weeks
Countries: multinational (189 sites)
Sponsor: F. Hoffmann-La Roche (industry)
Eligibility: age 18 to 75; HbA1c 7 to 10 percent; BMI 25 to 45 (above 23 for Asians); metformin with or without TZD

Conduct and analysis

Blinding: open label
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	Taspoglutide 10 mg subcutaneous once weekly Taspoglutide 10 mg weekly	metformin with or without thiazolidinedione; lifestyle: not reported	399	384
A2	Taspoglutide 20 mg subcutaneous once weekly Taspoglutide 20 mg weekly	metformin with or without thiazolidinedione; lifestyle: not reported	398	392
A3	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	metformin with or without thiazolidinedione; lifestyle: not reported	392	373

Baseline characteristics

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

Characteristic	Statistic	Taspoglutide 10 mg subcutaneous once weekly A1	Taspoglutide 20 mg subcutaneous once weekly A2	Exenatide 10 ug subcutaneous twice daily A3
age	mean (years)	56	56	55
age	sd (years)	9.6	10.0	9.9
bmi	mean (kg/m2)	33.5	33.1	33.8
bmi	sd (kg/m2)	5.2	5.3	5.2
diabetes duration	mean (years)	6.3	7.0	6.5
diabetes duration	sd (years)	5.2	5.7	5.4
hba1c: 8.0 or more	n	197	199	176
hba1c: 8.0 or more	percent	51	51	47
hba1c: less than 8.0	n	187	193	197
hba1c: less than 8.0	percent	49	49	53
hba1c	mean (percent)	8.1	8.1	8.1
hba1c	sd (percent)	0.9	0.9	0.9
hispanic	n	71	82	73
hispanic	percent	18	21	20
other background: metformin only	n	338	345	322
other background: metformin only	percent	88.0	88.0	86.3
other background: metformin thiazolidinedione	n	43	43	44
other background: metformin thiazolidinedione	percent	11.2	11.0	11.8
other background: thiazolidinedione only	n	3	4	7
other background: thiazolidinedione only	percent	0.8	1.0	1.9
other male	n	221	205	182
other male	percent	58	52	49
other race nonwhite	n	58	58	57
other race nonwhite	percent	15	15	15
sbp	mean (mmHg)	132.1	132.0	131.2
weight	mean (kg)	95.5	93.2	94.5
weight	sd (kg)	20.0	18.9	18.6
white	n	326	334	316
white	percent	85	85	85

Analyses this trial contributes to

Results

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

HbA1c change (10 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.24 percent	0.09		384	not stated; modified itt; R0013639:Results
24	A1 vs A3	md	-0.26 percent		-0.37 to -0.15		not stated; modified itt; R0013639:Results
24	A2	change	-1.31 percent	0.08		392	not stated; modified itt; R0013639:Results
24	A2 vs A3	md	-0.33 percent		-0.44 to -0.22		not stated; modified itt; R0013639:Results
24	A3	change	-0.98 percent	0.08		373	not stated; modified itt; R0013639:Results
52	A1	change	-1.16 percent	0.09		384	not stated; modified itt; R0013639:Results
52	A1 vs A3	md	-0.22 percent		-0.34 to -0.11		not stated; modified itt; R0013639:Results
52	A2	change	-1.18 percent	0.09		392	not stated; modified itt; R0013639:Results
52	A2 vs A3	md	-0.25 percent		-0.37 to -0.13		not stated; modified itt; R0013639:Results
52	A3	change	-0.94 percent	0.09		373	not stated; modified itt; R0013639:Results

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-1.6 kg	0.4	384	not stated; modified itt; R0013639:Results
24	A2	change	-2.3 kg	0.4	392	not stated; modified itt; R0013639:Results
24	A3	change	-2.3 kg	0.4	373	not stated; modified itt; R0013639:Results

Level 2 or 3 hypoglycemia (participants) (9 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		59 / 394	not stated; safety; R0013639:Table 2
A1	events	1.3	5 /	not stated; safety; R0013639:Results
A1	events		0 /	not stated; safety; R0013639:Results
A2	events		0 /	not stated; safety; R0013639:Results
A2	events	3.6	14 /	not stated; safety; R0013639:Results
A2	events		60 / 394	not stated; safety; R0013639:Table 2
A3	events	3.9	15 /	not stated; safety; R0013639:Results
A3	events		79 / 385	not stated; safety; R0013639:Table 2
A3	events		0 /	not stated; safety; R0013639:Results

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
52	A1	change	-2.18 mmHg	-4.63 to 0.26	384	not stated; modified itt; R0013639:Supplementary Table
52	A1 vs A3	md	0.20 mmHg	-1.46 to 1.87		not stated; modified itt; R0013639:Supplementary Table
52	A2	change	-2.02 mmHg	-4.46 to 0.42	392	not stated; modified itt; R0013639:Supplementary Table
52	A2 vs A3	md	-0.37 mmHg	-1.29 to 2.03		not stated; modified itt; R0013639:Supplementary Table
52	A3	change	-2.39 mmHg	-4.78 to 0.1	373	not stated; modified itt; R0013639:Supplementary Table

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	2 / 394	not stated; safety; R0013639:Table 2
A2	events	1 / 394	not stated; safety; R0013639:Table 2
A3	events	1 / 385	not stated; safety; R0013639:Table 2

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	50 / 394	not stated; safety; R0013639:Table 2
A2	events	33 / 394	not stated; safety; R0013639:Table 2
A3	events	38 / 385	not stated; safety; R0013639:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	103 / 394	not stated; safety; R0013639:Table 2
A2	events	135 / 394	not stated; safety; R0013639:Table 2
A3	events	60 / 385	not stated; safety; R0013639:Table 2

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	209 / 394	not stated; safety; R0013639:Table 2
A2	events	233 / 394	not stated; safety; R0013639:Table 2
A3	events	135 / 385	not stated; safety; R0013639:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	131 / 394	not stated; safety; R0013639:Table 2
A2	events	144 / 394	not stated; safety; R0013639:Table 2
A3	events	60 / 385	not stated; safety; R0013639:Table 2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	53 / 394	not stated; safety; R0013639:Table 2
A2	events	66 / 394	not stated; safety; R0013639:Table 2
A3	events	53 / 385	not stated; safety; R0013639:Table 2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	24 / 394	not stated; safety; R0013639:Table 2
A2	events	40 / 394	not stated; safety; R0013639:Table 2
A3	events	14 / 385	not stated; safety; R0013639:Table 2

Discontinuation due to gastrointestinal adverse events (12 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	55 / 394	not stated; safety; R0013639:Table 2
A1	events	3 / 394	not stated; safety; diarrhea; R0013639:Table 2
A1	events	25 / 394	not stated; safety; nausea; R0013639:Table 2
A1	events	19 / 394	not stated; safety; vomiting; R0013639:Table 2
A2	events	85 / 394	not stated; safety; R0013639:Table 2
A2	events	6 / 394	not stated; safety; diarrhea; R0013639:Table 2
A2	events	40 / 394	not stated; safety; nausea; R0013639:Table 2
A2	events	26 / 394	not stated; safety; vomiting; R0013639:Table 2
A3	events	39 / 385	not stated; safety; R0013639:Table 2
A3	events	3 / 385	not stated; safety; diarrhea; R0013639:Table 2
A3	events	22 / 385	not stated; safety; nausea; R0013639:Table 2
A3	events	8 / 385	not stated; safety; vomiting; R0013639:Table 2

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 /	not stated; safety; R0013639:Conclusions
A2	events	1 /	not stated; safety; R0013639:Results
A3	events	0 /	not stated; safety; R0013639:Conclusions

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Detail
A1	events	not stated; safety; R0013639:Results
A2	events	not stated; safety; R0013639:Results
A3	events	not stated; safety; R0013639:Results

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	1 /	not stated; safety; R0013639:Results
A2	events	0 /	not stated; safety; R0013639:Results
A3	events	0 /	not stated; safety; R0013639:Results