An indirect comparison of HbA_1c treatment effect with albiglutide and exenatide 2.0 mg QW using the Bucher method

Figures & data

Table 1 Comparative summary description of HARMONY 7 and DURATION 6

	HARMONY 7^Citation7	DURATION 6^Citation8
Design	Open-label, randomized, parallel-group Phase III study 32 weeks’ duration	Open-label, randomized, parallel-group Phase III study 26 weeks’ duration
Treatment arms	Albiglutide 30 mg QW titrated to 50 mg at week 6 Liraglutide 0.6 mg once daily titrated to 1.2 mg at week 1 and 1.8 mg at week 2	Exenatide 2.0 mg QW Liraglutide 0.6 mg once daily titrated to 1.2 mg at week 1 and 1.8 mg at week 2 (could be delayed if severe nausea or vomiting)
Primary endpoint	Change from baseline in HbA1c at 32 weeks; ITT population, LOCF	Change from baseline in HbA1c at 26 weeks; ITT population, LOCF
Population	Uncontrolled (HbA ≥7.0% and ≤10.0%) on 1c oral therapy Background oral therapy: metformin, thiazolidinediones, sulfonylureas, or any combination of these drugs BMI ≥20 kg/m^2 and ≤45 kg/m^2	Uncontrolled (HbA ≥7.1% and ≤11.0%) on oral 1c therapy Background oral therapy: metformin, sulfonylurea, metformin + sulfonylurea, or metformin + pioglitazone BMI ≤45 kg/m^2
	Generally similar exclusions for comorbid conditions
Test	Noninferiority test	Noninferiority test

Abbreviations: BMI, body mass index; HbA_1c, glycated hemoglobin; ITT, intent to treat; LOCF, last observation carried forward; QW, once weekly.

Table 2 Baseline characteristics of patients enrolled in HARMONY 7 and DURATION 6

Baseline characteristics; data are mean (SD) or %		HARMONY 7^Citation7		DURATION 6^Citation8
		Albiglutide	Liraglutide	Exenatide 2.0 mg QW	Liraglutide
	Age (years)	55.4 (10)	55.8 (10)	57 (9.4)	57 (9.6)
	Male (%)	47	53	55	54
	HbA1c (%)	8.18 (0.89)	8.15 (0.84)	8.5 (1.0)	8.4 (1.0)
	BMI (kg/m2)	32.8 (6.0)	32.8 (5.9)	32.3 (5.6)	32.3 (5.4)
	Duration of diabetes (years)	8.4 (6.1)	8.3 (5.6)	8 (6)	9 (6)

Abbreviations: BMI, body mass index; HbA_1C, glycated hemoglobin; QW, once weekly; SD, standard deviation.

Table 3 Results of indirect comparison analysis using Bucher method

		HARMONY 7^Citation7		DURATION 6^Citation8
		Albiglutide 50 mg (N=402)	Liraglutide 1.8 mg (N=403)	Exenatide 2.0 mg QW (N=390)	Liraglutide 1.8 mg (N=386)
HbA1c	LS mean difference from BL (SE)	−0.78 (0.047)	−0.99 (0.046)	−1.28 (0.05)	−1.48 (0.05)
	Treatment difference (95% CI) (%)	0.21 (0.08–0.34)		0.21 (0.08–0.33)
Noninferiority	• Mean difference (exenatide 2.0 mg QW albiglutide): 0.0
	• SE: 0.097
	• 95% CI of difference (exenatide 2.0 mg QW albiglutide): (−0.189 to 0.189)
	• Albiglutide 50 mg is noninferior to exenatide 2.0 mg QW P=0.002

Abbreviations: BL, baseline; CI, confidence interval; HbA_1C, glycated hemoglobin; LS, least squares; QW, once weekly; SE, standard error.

Figure 1 Forest plot of albiglutide vs exenatide 2.0 mg QW.

Abbreviations: QW, once weekly; LCL, 95% lower confidence limit; UCL, 95% upper confidence limit.

Pratley RE Nauck MA Barnett AH Once weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study Lancet Diabetes Endocrinol 2014 2 4 289 297 24703047

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Buse JB Nauck M Forst T Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study Lancet 2013 381 117 124 23141817

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