parallel randomized trial

NCT02887625

Efficacy and Durability of Glucagon Like Peptide 1 Receptor Agonists (GLP-1 RA)/Thiazolidinedione Versus Basal Bolus Insulin Therapy in Poorly Controlled Type 2 Diabetic Patients (T2DM) Patients on Sulfonylurea Plus Metformin

Type 2 diabetes (adults)NCT02887625S002035

Design

Randomized: 251
Start year: 2015
Treatment: 156.54 weeks, follow-up 156.54 weeks
Countries: Qatar (1 sites)
Sponsor: Muhammad Abdulghani (mixed)
Eligibility: age 18 to 75; HbA1c above 7.5 percent on near maximal metformin plus sulfonylurea

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: last available visit value

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release plus pioglitazone 2 to 30 mg injection once weekly Exenatide plus pioglitazone (combination therapy)	metformin plus sulfonylurea; lifestyle: not reported	129	123
A2	Basal bolus insulin Basal bolus insulin (insulin therapy)	metformin plus sulfonylurea; lifestyle: not reported	122	108

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release plus pioglitazone 2 to 30 mg injection once weekly A1	Basal bolus insulin A2
age	mean (years)	52	52
age	se (years)	1	1
asian: asian indian	percent	17	25
bmi	mean (kg/m2)	31.1	30.5
bmi	se (kg/m2)	0.5	0.5
diabetes duration	mean (years)	10.5	10.9
diabetes duration	se (years)	0.5	0.5
hba1c	mean (percent)	10.0	10.0
metformin use	percent	100	100
other ethnicity non qatari arab	percent	26	29
other ethnicity qatari	percent	48	39
other male	percent	40	37
other race asian indian	percent	17	25
other race other	percent	9	7

Analyses this trial contributes to

Results

39 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	Events / N	Detail
26.07	A1	final	6.7 percent			not stated; other; R0026120:Results
26.07	A2	final	7.4 percent			not stated; other; R0026120:Results
26.07	A2 vs A1	md	0.7 percent			not stated; other; R0026120:Results
52.14	A1	final	6.1 percent	0.1	123	not stated; other; R0026120:Abstract
52.14	A2	final	7.1 percent	0.1	108	not stated; other; R0026120:Abstract
52.14	A2 vs A1	md	0.9 percent			not stated; other; R0026120:Results
78.21	A2 vs A1	md	1 percent			not stated; other; R0026120:Results

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52.14	A1	change	2.1 kg				not stated; other; R0026120:Results
52.14	A2	change	4.2 kg				not stated; other; R0026120:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52.14	A1	responders	83			123	not stated; other; R0026120:Results
52.14	A2	responders	53			108	not stated; other; R0026120:Results

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	66	123	not stated; other; R0026120:Results
A1	events		0 / 123	not stated; other; R0026120:Supplementary Table 1
A2	events	91	108	not stated; other; R0026120:Results
A2	events		1 / 108	not stated; other; R0026120:Supplementary Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate	2.3			123	not stated; other; R0026120:Results
	A2	rate	6.6			108	not stated; other; R0026120:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Supplementary Table 1
	A2	events				1 / 108	not stated; other; R0026120:Supplementary Table 1

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Results
	A2	events				5 / 108	not stated; other; R0026120:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Results
	A2	events				0 / 108	not stated; other; R0026120:Results

Heart failure events (2 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Results
	A2	events				0 / 108	not stated; other; R0026120:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 129	not stated; randomized; R0026120:Results
A1	events	2 / 129	not stated; randomized; nausea; R0026120:Results
A1	events	2 / 129	not stated; randomized; peripheral edema; R0026120:Results
A2	events	0 / 122	not stated; randomized; R0026120:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	31			123	not stated; other; R0026120:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 129	not stated; randomized; nausea; R0026120:Results
	A2	events				0 / 122	not stated; randomized; R0026120:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Supplementary Table 1

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Supplementary Table 1

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Supplementary Table 1
	A2	events				0 / 108	not stated; other; R0026120:Supplementary Table 1

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Supplementary Table 1

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 123	not stated; other; R0026120:Supplementary Table 1
	A2	events				1 / 108	not stated; other; R0026120:Supplementary Table 1