parallel randomized trial

NCT00360334

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Type 2 diabetes (adults)NCT00360334S001323

Design

Randomized: 235
Start year: 2006
Treatment: 26 weeks, follow-up 26 weeks
Countries: United Kingdom (36 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: BMI above 27; HbA1c 7.5 to 10.0 percent; 2 or 3 oral drugs; at least one CV risk factor

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: nonresponder imputation for primary; MMRM and ANCOVA for continuous

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug BID	2 or 3 oral drugs (metformin, sulfonylurea, thiazolidinedione); sulfonylurea could be reduced for hypoglycemia; lifestyle: not reported	118	118
A2	Insulin glargine Insulin glargine QD titrated	2 or 3 oral drugs (metformin, sulfonylurea, thiazolidinedione); sulfonylurea could be reduced for hypoglycemia; lifestyle: not reported	117	116

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)	56.8	56.2
age	sd (years)	10.2	7.9
bmi	mean (kg/m2)	34.6	33.7
bmi	sd (kg/m2)	5.7	4.9
diabetes duration	mean (years)	9.0	8.4
diabetes duration	sd (years)	4.6	4.4
established cvd	n	16	21
established cvd	percent	13.6	18.1
female	n	35	39
hba1c	mean (percent)	8.65	8.48
hba1c	sd (percent)	0.68	0.66
other male	n	83	77
other male	percent	70.3	66.4
other oad combination: metformin sulfonylurea thiazolidinedione	n	48	47
other oad combination: metformin sulfonylurea thiazolidinedione	percent	40.7	40.5
other oad combination: metformin sulfonylurea	n	50	49
other oad combination: metformin sulfonylurea	percent	42.4	42.2
other oad combination: metformin thiazolidinedione	n	17	15
other oad combination: metformin thiazolidinedione	percent	14.4	12.9
other oad combination: sulfonylurea thiazolidinedione	n	2	4
other oad combination: sulfonylurea thiazolidinedione	percent	1.7	3.4
other sulfonylurea use	percent	84.7	86.2
other waist hip ratio	mean	0.99	0.98
other waist hip ratio	sd	0.08	0.08
sbp	mean (mmHg)	134.0	134.5
sbp	sd (mmHg)	14.9	17.5
waist	mean (cm)	112.07	110.64
waist	se (cm)	1.30	1.32
weight	mean (kg)	101.4	97.6
weight	sd (kg)	19.8	16.4

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.25 percent	0.09	-1.43 to -1.07	98	not stated; full analysis; R0024925:Table 2
26	A1 vs A2	md	0.01 percent		-0.24 to 0.27		not stated; full analysis; R0024925:Results
26	A2	change	-1.26 percent	0.09	-1.44 to -1.08	102	not stated; full analysis; R0024925:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-2.73 kg	0.31	-3.34 to -2.11	100	not stated; full analysis; R0024925:Table 2
26	A1	change	-2.73 kg	0.31		117	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-5.71 kg		-6.58 to -4.84		not stated; full analysis; R0024925:Results
26	A2	change	2.98 kg	0.31	2.37 to 3.60	104	not stated; full analysis; R0024925:Table 2
26	A2	change	2.98 kg	0.31		113	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	34.7		118	not stated; full analysis; registry:outcomes
26	A1 vs A2	or	0.70	0.42 to 1.19		not stated; full analysis; registry:outcomes
26	A2	responders	43.1		116	not stated; full analysis; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (10 lines; O04)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1 vs A2	or	0.80	0.24 to 2.71		not stated; full analysis; R0024925:Table 3
A1	events			5 / 118	not stated; full analysis; R0024925:Table 3
A1	events			59 / 118	not stated; full analysis; R0024925:Table 3
A1	events			37 / 118	not stated; full analysis; R0024925:Table 3
A1 vs A2	or	0.68	0.40 to 1.14		not stated; full analysis; R0024925:Table 3
A1 vs A2	or	0.78	0.45 to 1.35		not stated; full analysis; R0024925:Table 3
A2	events			6 / 116	not stated; full analysis; R0024925:Table 3
A2	events			68 / 116	not stated; full analysis; R0024925:Table 3
A2	events	5.3		114	not stated; full analysis; registry:outcomes
A2	events			42 / 116	not stated; full analysis; R0024925:Table 3

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1 vs A2	md	-3.6 mmHg			not stated; full analysis; R0024925:Results
26	A1	change	-2.9 mmHg	1.2	117	not stated; full analysis; R0024925:Table 2
26	A1	change	-3.6 mmHg	1.2	117	not stated; full analysis; registry:outcomes
26	A2	change	0.6 mmHg	1.2	113	not stated; full analysis; registry:outcomes
26	A2	change	0.7 mmHg	1.2	114	not stated; full analysis; R0024925:Table 2

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	percent change	-2.8 percent	0.3		117	not stated; full analysis; registry:outcomes
26	A2	percent change	3.1 percent	0.3		113	not stated; full analysis; registry:outcomes

Weight loss of 5 percent or more (3 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	19.5		118	not stated; full analysis; registry:outcomes
26	A1 vs A2	or	27.91	3.70 to 210.54		not stated; full analysis; registry:outcomes
26	A2	responders	0.9		116	not stated; full analysis; registry:outcomes

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	4.2			118	not stated; full analysis; registry:outcomes
26	A2	responders	0.0			116	not stated; full analysis; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 118	not stated; full analysis; renal failure acute; registry:adverse_events
	A2	events				0 / 116	not stated; full analysis; renal failure acute; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 118	not stated; full analysis; R0024925:Table 3
	A2	events				5 / 116	not stated; full analysis; R0024925:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	7 / 118	not stated; full analysis; R0024925:Table 3
A1	events	7 / 118	not stated; randomized; registry:flow
A2	events	4 / 116	not stated; full analysis; R0024925:Table 3
A2	events	4 / 117	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				57 / 118	not stated; full analysis; R0024925:Table 3
	A2	events				3 / 116	not stated; full analysis; R0024925:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				25 / 118	not stated; full analysis; registry:adverse_events
	A2	events				6 / 116	not stated; full analysis; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				22 / 118	not stated; full analysis; R0024925:Table 3
	A2	events				14 / 116	not stated; full analysis; R0024925:Table 3

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	1 / 118	not stated; full analysis; diarrhoea; R0024925:Results
A1	events	2 / 118	not stated; full analysis; nausea; R0024925:Results
A1	events	2 / 118	not stated; full analysis; vomiting; R0024925:Results
A2	events	0 / 116	not stated; full analysis; R0024925:Results