parallel randomized trial

NCT00423501

A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Type 2 diabetes (adults)NCT00423501S002003

Design

Randomized: 306
Start year: 2007
Treatment: 8 weeks, follow-up 12 weeks
Countries: multinational
Sponsor: Hoffmann-La Roche (industry)
Eligibility: age 18 to 75; metformin 1500 mg or more; HbA1c 7 to 9.5 percent; BMI 25 to 45

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Placebo Placebo weekly	metformin; lifestyle: none	49
A2	Taspoglutide 5 mg injection once weekly Taspoglutide 5 mg weekly	metformin; lifestyle: none	50
A3	Taspoglutide 10 mg subcutaneous once weekly Taspoglutide 10 mg weekly	metformin; lifestyle: none	49
A4	Taspoglutide 20 mg subcutaneous once weekly Taspoglutide 20 mg weekly	metformin; lifestyle: none	50
A5	Taspoglutide 10 mg injection every 2 weeks Taspoglutide 10 mg every 2 weeks	metformin; lifestyle: none	50
A6	Taspoglutide 20 mg injection every 2 weeks Taspoglutide 20 mg every 2 weeks	metformin; lifestyle: none	49

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Taspoglutide 5 mg injection once weekly A2	Taspoglutide 10 mg subcutaneous once weekly A3	Taspoglutide 20 mg subcutaneous once weekly A4	Taspoglutide 10 mg injection every 2 weeks A5	Taspoglutide 20 mg injection every 2 weeks A6
age	mean (years)	56	57	56	56	53	56
age	sd (years)	6	7	8	8	11	7
bmi	mean (kg/m2)	31.8	33.2	32.6	32.4	33.1	33.2
bmi	sd (kg/m2)	4.9	5.3	4.7	5.2	5.1	5.1
diabetes duration	mean (years)	5	6	5	5	5	6
diabetes duration	sd (years)	4	6	5	4	4	5
female	percent	57	48	39	64	48	55
hba1c	mean (percent)	8.0	7.9	7.9	7.8	8.0	7.9
hba1c	se (percent)	0.1	0.1	0.1	0.1	0.1	0.1
sbp	mean (mmHg)	129	127	128	131	132	132
sbp	sd (mmHg)	13	13	14	14	13	13

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
8	A1	change	-0.2 percent	0.1	49	not stated; modified itt; R0022337:Table 1
8	A2	change	-1.0 percent	0.1	50	not stated; modified itt; R0022337:Table 1
8	A3	change	-1.2 percent	0.1	49	not stated; modified itt; R0022337:Table 1
8	A4	change	-1.2 percent	0.1	50	not stated; modified itt; R0022337:Table 1
8	A5	change	-0.9 percent	0.1	50	not stated; modified itt; R0022337:Table 1
8	A6	change	-1.0 percent	0.1	49	not stated; modified itt; R0022337:Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
8	A1	change	-0.8 kg	0.3	49	not stated; modified itt; R0022337:Results
8	A3	change	-2.1 kg	0.3	49	not stated; modified itt; R0022337:Results
8	A4	change	-2.8 kg	0.3	50	not stated; modified itt; R0022337:Results
8	A6	change	-1.9 kg	0.3	49	not stated; modified itt; R0022337:Results

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
8	A1	responders	17	49	not stated; modified itt; R0022337:Results
8	A3	responders	79	49	not stated; modified itt; R0022337:Results
8	A4	responders	81	50	not stated; modified itt; R0022337:Results

Level 2 or 3 hypoglycemia (participants) (5 lines; O04)

Arm	Statistic	Events / N	Detail
A2	events	0 / 50	not stated; safety; R0022337:Results
A3	events	0 / 49	not stated; safety; R0022337:Results
A4	events	0 / 50	not stated; safety; R0022337:Results
A5	events	0 / 50	not stated; safety; R0022337:Results
A6	events	0 / 49	not stated; safety; R0022337:Results

Serious adverse events (1 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 49	not stated; safety; R0022337:Results

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	3 / 49	not stated; safety; R0022337:Table 2
A2	events	11 / 50	not stated; safety; R0022337:Table 2
A3	events	12 / 49	not stated; safety; R0022337:Table 2
A4	events	26 / 50	not stated; safety; R0022337:Table 2
A5	events	16 / 50	not stated; safety; R0022337:Table 2
A6	events	20 / 49	not stated; safety; R0022337:Table 2

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 49	not stated; safety; R0022337:Table 2
A2	events	2 / 50	not stated; safety; R0022337:Table 2
A3	events	2 / 49	not stated; safety; R0022337:Table 2
A4	events	11 / 50	not stated; safety; R0022337:Table 2
A5	events	6 / 50	not stated; safety; R0022337:Table 2
A6	events	12 / 49	not stated; safety; R0022337:Table 2

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	4 / 49	not stated; safety; R0022337:Table 2
A2	events	4 / 50	not stated; safety; R0022337:Table 2
A3	events	5 / 49	not stated; safety; R0022337:Table 2
A4	events	5 / 50	not stated; safety; R0022337:Table 2
A5	events	8 / 50	not stated; safety; R0022337:Table 2
A6	events	9 / 49	not stated; safety; R0022337:Table 2

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				1 / 49	not stated; safety; nausea; R0022337:Results
	A4	events				2 / 50	not stated; safety; nausea; R0022337:Results

Acute pancreatitis (6 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 49	not stated; safety; R0022337:Results
A2	events	0 / 50	not stated; safety; R0022337:Results
A3	events	0 / 49	not stated; safety; R0022337:Results
A4	events	0 / 50	not stated; safety; R0022337:Results
A5	events	0 / 50	not stated; safety; R0022337:Results
A6	events	0 / 49	not stated; safety; R0022337:Results