parallel randomized trial

NCT00744926

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Type 2 diabetes (adults)NCT00744926S001638

Design

Randomized: 373
Start year: 2008
Treatment: 24 weeks, follow-up 24 weeks
Countries: multinational (53 sites)
Sponsor: F. Hoffmann-La Roche (industry)
Eligibility: age 18 to 80; drug naive; HbA1c 6.5 to 10 percent; BMI 25 to 45

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Placebo Placebo	none, drug naive; lifestyle: not reported	123
A2	Taspoglutide 10 mg subcutaneous once weekly Taspoglutide 10 mg weekly	none, drug naive; lifestyle: not reported	116
A3	Taspoglutide 20 mg subcutaneous once weekly Taspoglutide 20 mg weekly	none, drug naive; lifestyle: not reported	129

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
hba1c	mean (percent)			7.7

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Detail
24	A1	change	-0.09 percent	0.07	not stated; modified itt; R0025346:Results
24	A2	change	-0.69 percent		not stated; modified itt; hba1c:less_than_8; R0025346:Results
24	A2	change	-1.01 percent	0.07	not stated; modified itt; R0025346:Results
24	A2	change	-1.69 percent		not stated; modified itt; hba1c:8_or_more; R0025346:Results
24	A3	change	-1.72 percent		not stated; modified itt; hba1c:8_or_more; R0025346:Results
24	A3	change	-1.18 percent	0.06	not stated; modified itt; R0025346:Results
24	A3	change	-0.93 percent		not stated; modified itt; hba1c:less_than_8; R0025346:Results

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

Week	Arm	Statistic	Estimate	SE or SD	Detail
24	A1	change	-1.23 kg	0.31	not stated; modified itt; R0025346:Abstract
24	A2	change	-1.45 kg	0.32	not stated; modified itt; R0025346:Abstract
24	A3	change	-2.25 kg	0.30	not stated; modified itt; R0025346:Abstract

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Detail
24	A1	responders	40	not stated; modified itt; R0025346:Results
24	A2	responders	80	not stated; modified itt; R0025346:Results
24	A3	responders	83	not stated; modified itt; R0025346:Results

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

Arm	Statistic	Events / N	Detail
A1	events	1 / 123	while on treatment; safety; R0025346:Table 1
A1	events	0 / 123	not stated; safety; R0025346:Results
A2	events	0 / 116	not stated; safety; R0025346:Results
A2	events	6 / 116	while on treatment; safety; R0025346:Table 1
A3	events	5 / 129	while on treatment; safety; R0025346:Table 1
A3	events	0 / 129	not stated; safety; R0025346:Results

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 123	not stated; safety; R0025346:Results
A2	events	0 / 116	not stated; safety; R0025346:Results
A3	events	0 / 129	not stated; safety; R0025346:Results

Serious adverse events (24 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 123	not stated; safety; abdominal pain; R0025346:Table 1
A1	events	0 / 123	not stated; safety; angina pectoris; R0025346:Table 1
A1	events	1 / 123	not stated; safety; benign prostatic hypertrophy; R0025346:Table 1
A1	events	0 / 123	not stated; safety; hypersensitivity; R0025346:Table 1
A1	events	0 / 123	not stated; safety; hypertension; R0025346:Table 1
A1	events	0 / 123	not stated; safety; ischemic stroke; R0025346:Table 1
A1	events	0 / 123	not stated; safety; neck pain; R0025346:Table 1
A1	events	1 / 123	not stated; safety; unstable angina; R0025346:Table 1
A2	events	1 / 116	not stated; safety; abdominal pain; R0025346:Table 1
A2	events	0 / 116	not stated; safety; angina pectoris; R0025346:Table 1
A2	events	0 / 116	not stated; safety; benign prostatic hypertrophy; R0025346:Table 1
A2	events	1 / 116	not stated; safety; hypersensitivity; R0025346:Table 1
A2	events	1 / 116	not stated; safety; hypertension; R0025346:Table 1
A2	events	1 / 116	not stated; safety; ischemic stroke; R0025346:Table 1
A2	events	0 / 116	not stated; safety; neck pain; R0025346:Table 1
A2	events	0 / 116	not stated; safety; unstable angina; R0025346:Table 1
A3	events	0 / 129	not stated; safety; abdominal pain; R0025346:Table 1
A3	events	1 / 129	not stated; safety; angina pectoris; R0025346:Table 1
A3	events	0 / 129	not stated; safety; benign prostatic hypertrophy; R0025346:Table 1
A3	events	1 / 129	not stated; safety; hypersensitivity; R0025346:Table 1
A3	events	0 / 129	not stated; safety; hypertension; R0025346:Table 1
A3	events	0 / 129	not stated; safety; ischemic stroke; R0025346:Table 1
A3	events	1 / 129	not stated; safety; neck pain; R0025346:Table 1
A3	events	0 / 129	not stated; safety; unstable angina; R0025346:Table 1

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 123	not stated; safety; R0025346:Table 1
A2	events	13 / 116	not stated; safety; R0025346:Table 1
A3	events	17 / 129	not stated; safety; R0025346:Table 1

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	5 / 123	while on treatment; safety; R0025346:Table 1
A2	events	30 / 116	while on treatment; safety; R0025346:Table 1
A3	events	40 / 129	while on treatment; safety; R0025346:Table 1

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 123	while on treatment; safety; R0025346:Table 1
A2	events	20 / 116	while on treatment; safety; R0025346:Table 1
A3	events	23 / 129	while on treatment; safety; R0025346:Table 1

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	5 / 123	while on treatment; safety; R0025346:Table 1
A2	events	16 / 116	while on treatment; safety; R0025346:Table 1
A3	events	12 / 129	while on treatment; safety; R0025346:Table 1

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

Arm	Statistic	Events / N	Detail
A1	events	1 / 123	not stated; safety; diarrhea; R0025346:Table 1
A1	events	0 / 123	not stated; safety; nausea; R0025346:Table 1
A1	events	0 / 123	not stated; safety; other gastrointestinal events; R0025346:Table 1
A1	events	0 / 123	not stated; safety; vomiting; R0025346:Table 1
A2	events	2 / 116	not stated; safety; diarrhea; R0025346:Table 1
A2	events	1 / 116	not stated; safety; nausea; R0025346:Table 1
A2	events	0 / 116	not stated; safety; other gastrointestinal events; R0025346:Table 1
A2	events	4 / 116	not stated; safety; vomiting; R0025346:Table 1
A3	events	0 / 129	not stated; safety; diarrhea; R0025346:Table 1
A3	events	5 / 129	not stated; safety; nausea; R0025346:Table 1
A3	events	4 / 129	not stated; safety; other gastrointestinal events; R0025346:Table 1
A3	events	2 / 129	not stated; safety; vomiting; R0025346:Table 1

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 123	not stated; safety; R0025346:Results
A2	events	0 / 116	not stated; safety; R0025346:Results
A3	events	0 / 129	not stated; safety; R0025346:Results

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 123	not stated; safety; R0025346:Results
A2	events	0 / 116	not stated; safety; R0025346:Results
A3	events	0 / 129	not stated; safety; R0025346:Results