parallel randomized trial

NCT02325960

A Comparison of Exenatide and Insulin Glargine on Glycemic Variability in T2DM Patients Inadequately Controlled With Metformin Monotherapy

Type 2 diabetes (adults)NCT02325960S000058

Design

Randomized: 45
Start year: 2015
Treatment: 16 weeks, follow-up 16 weeks
Countries: China (1 sites)
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (mixed)
Eligibility: age 18 to 70; BMI 24 or more; HbA1c 7.0 to 10.0 percent; metformin 1.5 g/day or more

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	metformin; lifestyle: standard	22	19
A2	Insulin glargine Insulin glargine	metformin; lifestyle: standard	23	20

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	Insulin glargine A2
age	mean (years)	46.74	49.45
age	se (years)	2.31	2.17
bmi	mean (kg/m2)	28.03	27.08
bmi	se (kg/m2)	0.50	0.52
diabetes duration	mean (years)	6.37	4.35
diabetes duration	se (years)	0.99	0.68
female	n	7	10
hba1c	mean (percent)	8.01	8.35
hba1c	se (percent)	0.21	0.24
sbp	mean (mmHg)	119.4	114.7
sbp	se (mmHg)	3.5	2.9
waist	mean (cm)	96.74	93.70
waist	se (cm)	1.50	1.52
weight	mean (kg)	80.36	74.75
weight	se (kg)	2.35	1.95

Analyses this trial contributes to

Results

63 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
16	A1	change	-1.21 percent		-1.57 to -0.85	19	not stated; completers; R0018635:Table 2
16	A1	change	-1.20 percent			19	not stated; completers; R0024438:Results
16	A1	final	6.83 percent	0.25		19	not stated; completers; R0018635:Table 2
16	A1	final	6.8 percent	0.3		19	not stated; completers; R0024438:Table 1
16	A1 vs A2	md	-0.16 percent		-0.67 to 0.35		not stated; completers; R0018635:Table 2
16	A1 vs A2	md	-0.1 percent		-0.7 to 0.6		not stated; completers; R0024438:Table 1
16	A2	change	-1.05 percent		-1.41 to -0.69	20	not stated; completers; R0018635:Table 2
16	A2	change	-1.1 percent			18	not stated; completers; R0024438:Results
16	A2	final	7.14 percent	0.16		20	not stated; completers; R0018635:Table 2
16	A2	final	7.1 percent	0.2		18	not stated; completers; R0024438:Table 1

Body weight change in kilograms (diabetes) (8 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	-3.51 kg		-5.09 to -1.93	19	not stated; completers; R0018635:Table 1
16	A1	final	76.85 kg	2.36		19	not stated; completers; R0018635:Table 1
16	A1	final	77.3 kg	2.4		19	not stated; completers; R0024438:Table 1
16	A1 vs A2	md	-3.96 kg		-5.65 to -2.27		not stated; completers; R0018635:Table 1
16	A1 vs A2	md	-4.5 kg		-6.3 to -2.7		not stated; completers; R0024438:Table 1
16	A2	change	0.45 kg		-0.37 to 1.27	20	not stated; completers; R0018635:Table 1
16	A2	final	75.20 kg	1.98		20	not stated; completers; R0018635:Table 1
16	A2	final	76.0 kg	1.8		18	not stated; completers; R0024438:Table 1

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 22	not stated; safety; R0024438:Results
A1	events	0 / 22	not stated; safety; R0024438:Results
A1	events	0 / 22	not stated; safety; R0024438:Results
A2	events	0 / 23	not stated; safety; R0024438:Results
A2	events	0 / 23	not stated; safety; R0024438:Results
A2	events	0 / 23	not stated; safety; R0024438:Results

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate				22	not stated; safety; R0024438:Results
	A2	rate				23	not stated; safety; R0024438:Results

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	final	120.9 mmHg	3.2		19	not stated; completers; R0024438:Table 1
16	A1 vs A2	md	-2.1 mmHg		-11.3 to 7.0		not stated; completers; R0024438:Table 1
16	A2	final	118.3 mmHg	3.9		18	not stated; completers; R0024438:Table 1

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 22	not stated; safety; R0024438:Results
	A2	events				0 / 23	not stated; safety; R0024438:Results

Three point MACE (1 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Four point MACE including unstable angina (1 lines; O21B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 22	not stated; safety; R0024438:Results
	A2	events				0 / 23	not stated; safety; R0024438:Results

Heart failure events (1 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 22	not stated; safety; R0024438:Results
	A2	events				0 / 23	not stated; safety; R0024438:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 22	not stated; safety; R0024438:Results
A2	events	0 / 23	not stated; safety; R0024438:Results
A2	events	0 / 23	not stated; safety; R0024438:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 22	not stated; safety; R0024438:Results
	A2	events				0 / 23	not stated; safety; R0024438:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 22	not stated; safety; R0024438:Results
A2	events	0 / 23	not stated; safety; R0024438:Results
A2	events	0 / 23	not stated; safety; R0024438:Results

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Diabetic retinopathy complications (1 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Nonarteritic anterior ischemic optic neuropathy (1 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Suicidal ideation or behavior (1 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 22	not stated; safety; R0024438:Results
	A2	events				0 / 23	not stated; safety; R0024438:Results

Gastroparesis (1 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Intestinal obstruction or ileus (1 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results

Any cancer (1 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 23	not stated; safety; R0024438:Results