parallel randomized trial

NCT00971659

Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily

Type 2 diabetes (adults)NCT00971659S001719

Design

Randomized: 48
Start year: 2008
Treatment: 4 weeks, follow-up 5.43 weeks
Countries: Germany (1 sites)
Sponsor: Profil Institut fuer Stoffwechselforschung (funded by sanofi-aventis) (industry)
Eligibility: age 35 to 70; T2D 6 months to 10 years; HbA1c 7 to 10 percent; BMI 21 to 39.9

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: none

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Exenatide 10 ug subcutaneous twice daily Exenatide plus glargine and metformin	insulin glargine titrated to fasting glucose 100 mg/dL plus metformin; lifestyle: not reported	16	15
A2	Sitagliptin Sitagliptin plus glargine and metformin	insulin glargine titrated to fasting glucose 100 mg/dL plus metformin; lifestyle: not reported	16	16
A3	Standard care or no added treatment Glargine plus metformin continued	insulin glargine titrated to fasting glucose 100 mg/dL plus metformin; lifestyle: not reported	16	16

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	Sitagliptin A2	Standard care or no added treatment A3	Whole trial ALL
age	mean (years)				57
age	sd (years)				7
bmi	mean (kg/m2)				31.7
bmi	sd (kg/m2)				3.4
diabetes duration	mean (years)				6
diabetes duration	sd (years)				1
hba1c	mean (percent)	8.39	7.89	7.91
hba1c	sd (percent)	0.98	0.48	0.57
insulin dose	mean (U/kg/day)	0.60	0.50	0.50
insulin dose	sd (U/kg/day)	0.25	0.20	0.21
other male	percent				60.4

Analyses this trial contributes to

Results

28 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	Events / N	Detail
4	A1	change	-1.8 percent		15	not stated; modified itt; R0027899:Table 1
4	A1	change	-1.9 percent	0.7		not stated; modified itt; R0027899:Abstract
4	A1	final	6.53 percent	0.59	15	not stated; modified itt; R0027899:Table 1
4	A1 vs A3	md	-0.6 percent			not stated; modified itt; R0027899:Results
4	A2	change	-1.49 percent		16	not stated; modified itt; R0027899:Table 1
4	A2	change	-1.5 percent	0.7		not stated; modified itt; R0027899:Abstract
4	A2	final	6.41 percent	0.50	16	not stated; modified itt; R0027899:Table 1
4	A3	change	-1.23 percent		16	not stated; modified itt; R0027899:Table 1
4	A3	change	-1.2 percent	0.5		not stated; modified itt; R0027899:Abstract
4	A3	final	6.73 percent	0.42	16	not stated; modified itt; R0027899:Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
4	A1	change	-0.9 kg	1.7	15	not stated; modified itt; R0027899:Table 1
4	A2	change	0.1 kg	1.6	16	not stated; modified itt; R0027899:Table 1
4	A3	change	0.4 kg	1.5	16	not stated; modified itt; R0027899:Table 1

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
4	A1	responders	80.0	15	not stated; modified itt; R0027899:Abstract
4	A2	responders	87.5	16	not stated; modified itt; R0027899:Abstract
4	A3	responders	62.5	16	not stated; modified itt; R0027899:Abstract

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 16	not stated; modified itt; R0027899:Results
A2	events	0 / 16	not stated; modified itt; R0027899:Results
A3	events	0 / 16	not stated; modified itt; R0027899:Results

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

Arm	Statistic	Estimate	Detail
A1	rate	1.68	not stated; modified itt; R0027899:Table 1
A2	rate	2.45	not stated; modified itt; R0027899:Table 1
A3	rate	1.62	not stated; modified itt; R0027899:Table 1

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 16	not stated; modified itt; R0027899:Results
A2	events	0 / 16	not stated; modified itt; R0027899:Results
A3	events	0 / 16	not stated; modified itt; R0027899:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 16	not stated; modified itt; R0027899:Results
A2	events	0 / 16	not stated; modified itt; R0027899:Abstract
A3	events	0 / 16	not stated; modified itt; R0027899:Abstract