parallel randomized trial

NCT00308139

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications

Type 2 diabetes (adults)NCT00308139S002279

Design

Randomized: 303
Start year: 2006
Treatment: 30 weeks, follow-up 30 weeks
Countries
Sponsor: Amylin Pharmaceuticals;Eli Lilly and Company (industry)
Eligibility: age 18 or older; HbA1c 7.1 to 11.0 percent; BMI 25 to 45 kg/m2

Conduct and analysis

Blinding: open label
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	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly 2 mg	diet and exercise or oral agents (metformin, sulfonylurea, thiazolidinedione); lifestyle: not reported	152	148
A2	Exenatide 10 ug subcutaneous twice daily Exenatide twice daily 10 ug	diet and exercise or oral agents (metformin, sulfonylurea, thiazolidinedione); lifestyle: not reported	151	147

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Exenatide 10 ug subcutaneous twice daily A2
age: 18 or less	n	0	0
age: 18 to 65	n	122	123
age: 65 or older	n	26	24
age	mean (years)	55	55
age	sd (years)	10	10
asian	n	0	1
asian	percent	0	1
black	n	9	19
black	percent	6	13
bmi	mean (kg/m2)	35	35
bmi	sd (kg/m2)	5	5
diabetes duration	mean (years)	7	6
diabetes duration	sd (years)	6	5
female	n	66	72
female	percent	45	49
hba1c	mean (percent)	8.3	8.3
hba1c	sd (percent)	1.0	1.0
hispanic	n	16	20
hispanic	percent	11	14
metformin use	n	114	102
metformin use	percent	77	69
other background: diet and exercise	n	21	23
other background: diet and exercise	percent	14	16
other background: metformin and sulfonylurea	n	43	39
other background: metformin and sulfonylurea	percent	29	27
other background: metformin and thiazolidinedione	n	13	11
other background: metformin and thiazolidinedione	percent	9	8
other background: metformin only	n	56	50
other background: metformin only	percent	38	34
other background: metformin sulfonylurea and thiazolidinedione	n	1	0
other background: sulfonylurea and thiazolidinedione	n	5	5
other background: sulfonylurea only	n	6	10
other background: sulfonylurea only	percent	4	7
other background: thiazolidinedione only	n	2	7
other background: thiazolidinedione only	percent	1	5
other sulfonylurea use	n	55	54
other sulfonylurea use	percent	37	37
other tzd use	n	22	25
other tzd use	percent	15	17
sbp	mean (mmHg)	128	130
weight	mean (kg)	102	102
weight	sd (kg)	19	21
white	n	123	107
white	percent	83	73

Results

58 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	95% CI	Events / N	Detail
30	A1	change	-2.1 percent		-2.2 to -1.9	120	not stated; completers; R0019054:Results
30	A1	change	-1.9 percent				not stated; other; R0027199:Research design and methods
30	A1	change	-1.87 percent	0.082	-2.03 to -1.71	148	not stated; modified itt; registry:outcomes
30	A1 vs A2	md	-0.33 percent	0.107	-0.54 to -0.12		not stated; modified itt; registry:outcomes
30	A2	change	-1.8 percent		-1.9 to -1.6	121	not stated; completers; R0019054:Results
30	A2	change	-1.5 percent				not stated; other; R0027199:Research design and methods
30	A2	change	-1.54 percent	0.082	-1.70 to -1.38	147	not stated; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	-3.67 kg	0.468	-4.59 to -2.75	148	not stated; modified itt; registry:outcomes
30	A1 vs A2	md	-0.08 kg	0.612	-1.29 to 1.12		not stated; modified itt; registry:outcomes
30	A2	change	-3.59 kg	0.468	-4.51 to -2.67	147	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	responders	70.9			148	not stated; modified itt; registry:outcomes
30	A2	responders	51.0			147	not stated; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0027199:Research design and methods
	A2	events				0 /	not stated; other; R0027199:Research design and methods

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate					not stated; other; R0027199:Research design and methods
	A2	rate					not stated; other; R0027199:Research design and methods

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	-4.4 mmHg	1.04		126	not stated; modified itt; registry:outcomes
30	A2	change	-3.8 mmHg	1.28		130	not stated; modified itt; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 148	not stated; safety; registry:adverse_events
	A2	events				1 / 145	not stated; safety; registry:adverse_events

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 148	not stated; safety; cardiac failure congestive; registry:adverse_events
	A2	events				0 / 145	not stated; safety; cardiac failure congestive; registry:adverse_events

Physical functioning (any instrument) (2 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	12.06 points	1.20	9.67 to 14.45	126	not stated; modified itt; R0027199:Table 2
30	A2	change	9.55 points	1.21	7.17 to 11.92	130	not stated; modified itt; R0027199:Table 2

Health related quality of life total score (any instrument) (4 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	5.17 points	0.54	4.11 to 6.23	137	not stated; modified itt; R0027199:Table 2
30	A1	change	10.23 points	0.89	8.48 to 11.97	143	not stated; modified itt; R0027199:Table 2
30	A2	change	3.97 points	0.53	2.94 to 5.01	142	not stated; modified itt; R0027199:Table 2
30	A2	change	8.61 points	0.88	6.88 to 10.34	143	not stated; modified itt; R0027199:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 148	not stated; safety; registry:adverse_events
	A2	events				5 / 145	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 148	not stated; modified itt; R0019054:Figure 1
	A2	events				8 / 147	not stated; modified itt; R0019054:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				40 / 148	not stated; safety; registry:adverse_events
	A2	events				49 / 145	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 148	not stated; safety; registry:adverse_events
	A2	events				27 / 145	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	24 / 148	not stated; safety; registry:adverse_events
A1	events	0 / 148	not stated; safety; registry:adverse_events
A2	events	18 / 145	not stated; safety; registry:adverse_events
A2	events	0 / 145	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 148	not stated; safety; registry:adverse_events
	A2	events				9 / 145	not stated; safety; registry:adverse_events

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 148	not stated; modified itt; nausea or vomiting; R0027199:Research design and methods
	A2	events				2 / 147	not stated; modified itt; nausea or vomiting; R0027199:Research design and methods

Gallbladder and biliary disease (8 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 148	not stated; safety; bile duct stenosis; registry:adverse_events
A1	events	1 / 148	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	0 / 148	not stated; safety; cholecystitis; registry:adverse_events
A1	events	0 / 148	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 145	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 145	not stated; safety; cholecystitis; registry:adverse_events
A2	events	0 / 145	not stated; safety; bile duct stenosis; registry:adverse_events
A2	events	0 / 145	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 148	not stated; safety; pancreatitis; registry:adverse_events
	A2	events				0 / 145	not stated; safety; pancreatitis; registry:adverse_events

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 148	not stated; safety; ileus; registry:adverse_events
	A2	events				0 / 145	not stated; safety; ileus; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 148	not stated; safety; registry:adverse_events
	A2	events				0 / 145	not stated; safety; registry:adverse_events