parallel randomized trial

S003079

Type 2 diabetes (adults)S003079

Design

Randomized: 36
Start year: 2010
Treatment: 5 weeks, follow-up 5 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: age 18 to 80, HbA1c 7.5 to 12 percent, BMI 21 to 35, T2D at least 6 months

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide + CSII group	CSII insulin aspart titrated by fasting and postprandial glucose; lifestyle: none	18
A2	Standard care or no added treatment CSII group	CSII insulin aspart titrated by fasting and postprandial glucose; lifestyle: none	18

Baseline characteristics

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Standard care or no added treatment A2	Whole trial ALL
age	mean (years)	47.56	49.92
age	sd (years)	13.15	9.46
bmi	mean (kg/m2)	26.59	26.25
bmi	sd (kg/m2)	3.33	4.72
diabetes duration	mean (years)			11.98
diabetes duration	sd (years)			7.83
hba1c	mean (percent)	9.67	8.84
hba1c	sd (percent)	1.34	1.38
insulin dose	mean (U/kg/day)	0.55	0.54
insulin dose	sd (U/kg/day)	0.08	0.08
weight	mean (kg)	75.78	71.5
weight	sd (kg)	5.14	14.72

Analyses this trial contributes to

Results

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

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

Week	Arm	Statistic	Estimate	SE or SD	Detail
5	A1	change	-4.44 kg	2.31	not stated; other; R0025923:Results
5	A1	final	71.33 kg	5.18	not stated; other; R0025923:Table 2
5	A2	change	-2.5 kg	1.18	not stated; other; R0025923:Results
5	A2	final	69.0 kg	14.43	not stated; other; R0025923:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Four point MACE including unstable angina (2 lines; O21B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Heart failure events (2 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Gastroparesis (2 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025923:Results
	A2	events				0 / 18	not stated; safety; R0025923:Results