parallel randomized trial

NCT00460941

A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Type 2 diabetes (adults)NCT00460941S001597

Design

Randomized: 133
Start year: 2007
Treatment: 8 weeks, follow-up 12 weeks
Countries: Australia, France, Germany, Mexico, Peru, USA (27 sites)
Sponsor: F. Hoffmann-La Roche (industry)
Eligibility: age 18 to 75; HbA1c 7.0 to 9.5 percent on metformin; BMI above 25 to 45

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Placebo Placebo	metformin stable dose; lifestyle: none	32
A2	Taspoglutide 20 mg subcutaneous once weekly Taspoglutide 20/20 mg	metformin stable dose; lifestyle: none	32
A3	Taspoglutide 30 mg injection once weekly Taspoglutide 20/30 mg	metformin; lifestyle: none	33
A4	Taspoglutide 40 mg injection once weekly Taspoglutide 20/40 mg	metformin; lifestyle: none	32

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Taspoglutide 20 mg subcutaneous once weekly A2	Taspoglutide 30 mg injection once weekly A3	Taspoglutide 40 mg injection once weekly A4
age	mean (years)	56	57	55	60
age	se (years)	2	2	2	2
bmi	mean (kg/m2)	33.2	33.3	31.6	31.5
bmi	se (kg/m2)	1.0	0.9	1.0	0.9
diabetes duration	mean (years)	7	6	8	7
diabetes duration	se (years)	1	1	1	1
female	n	19	17	18	19
female	percent	59	53	55	59
hba1c	mean (percent)	7.8	8.0	8.0	7.8
hba1c	se (percent)	0.1	0.1	0.1	0.1
weight	mean (kg)	92.9	89.8	88.3	90.2
weight	se (kg)	3.5	3.8	3.0	3.9

Analyses this trial contributes to

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Detail
8	A1	change	-0.5 percent	0.1	not stated; modified itt; R0021258:Results
8	A2	change	-1.2 percent	0.1	not stated; modified itt; R0021258:Results
8	A3	change	-0.9 percent	0.1	not stated; modified itt; R0021258:Results
8	A4	change	-1.2 percent	0.1	not stated; modified itt; R0021258:Results

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Detail
8	A1	change	-2.0 kg	0.3	not stated; modified itt; R0021258:Results
8	A2	change	-2.1 kg	0.4	not stated; modified itt; R0021258:Results
8	A3	change	-3.0 kg	0.3	not stated; modified itt; R0021258:Results
8	A4	change	-2.7 kg	0.4	not stated; modified itt; R0021258:Results

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Detail
8	A1	responders	19	not stated; modified itt; R0021258:Results
8	A2	responders	72	not stated; modified itt; R0021258:Results
8	A3	responders	53	not stated; modified itt; R0021258:Results
8	A4	responders	70	not stated; modified itt; R0021258:Results

Level 2 or 3 hypoglycemia (participants) (8 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 32	not stated; safety; R0021258:Results
A1	events	1 / 32	not stated; safety; R0021258:Results
A2	events	1 / 32	not stated; safety; R0021258:Results
A2	events	0 / 32	not stated; safety; R0021258:Results
A3	events	0 / 33	not stated; safety; R0021258:Results
A3	events	3 / 33	not stated; safety; R0021258:Results
A4	events	0 / 32	not stated; safety; R0021258:Results
A4	events	2 / 32	not stated; safety; R0021258:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 32	not stated; safety; R0021258:Results
	A3	events				0 / 33	not stated; safety; R0021258:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 32	not stated; safety; R0021258:Results
	A3	events				0 / 33	not stated; safety; R0021258:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 32	not stated; safety; R0021258:Results
A2	events	0 / 32	not stated; safety; R0021258:Results
A3	events	0 / 33	not stated; safety; R0021258:Results
A4	events	1 / 32	not stated; safety; R0021258:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 32	not stated; safety; R0021258:Results
A2	events	0 / 32	not stated; safety; R0021258:Results
A3	events	2 / 33	not stated; safety; R0021258:Results
A4	events	4 / 32	not stated; safety; R0021258:Results

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	4 / 32	while on treatment; safety; R0021258:Table 2
A2	events	12 / 32	while on treatment; safety; R0021258:Table 2
A3	events	17 / 33	while on treatment; safety; R0021258:Table 2
A4	events	11 / 32	while on treatment; safety; R0021258:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 32	while on treatment; safety; R0021258:Table 2
A2	events	4 / 32	while on treatment; safety; R0021258:Table 2
A3	events	9 / 33	while on treatment; safety; R0021258:Table 2
A4	events	4 / 32	while on treatment; safety; R0021258:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 32	while on treatment; safety; R0021258:Table 2
A2	events	4 / 32	while on treatment; safety; R0021258:Table 2
A3	events	7 / 33	while on treatment; safety; R0021258:Table 2
A4	events	3 / 32	while on treatment; safety; R0021258:Table 2

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 32	not stated; safety; R0021258:Results
A2	events	0 / 32	not stated; safety; R0021258:Results
A3	events	2 / 33	not stated; safety; R0021258:Results
A4	events	1 / 32	not stated; safety; R0021258:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 32	not stated; safety; R0021258:Results
	A3	events				0 / 33	not stated; safety; R0021258:Results