parallel randomized trial

ELIXIRS

A Phase 4, Mono-center, Randomized, Open Label, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist Lixisenatide Versus Insulin Glulisine on Renal Physiology and Biomarkers in Insulin Glargine-treated Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT02276196S000423

Design

Randomized: 40
Start year: 2014
Treatment: 8 weeks
Countries: Netherlands (1 sites)
Sponsor: VU University Medical Center Amsterdam (industry)
Eligibility: age 35 to 75; BMI above 25; eGFR 60 or more; insulin glargine with or without metformin

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin glulisine (prandial) Insulin glulisine once daily	insulin glargine with or without metformin; lifestyle: none		18
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug once daily	insulin glargine with or without metformin; lifestyle: none		17

Baseline characteristics

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

Characteristic	Statistic	Insulin glulisine (prandial) A1	Lixisenatide 20 ug subcutaneous once daily A2
age	mean (years)	61	62
age	sd (years)	7	7
bmi	mean (kg/m2)	31.5	31.4
bmi	sd (kg/m2)	4.1	4.1
diabetes duration	mean (years)	14	11
diabetes duration	sd (years)	8	5
egfr	mean (mL/min/1.73 m2)	82	89
egfr	sd (mL/min/1.73 m2)	12	11
hba1c	mean (percent)	7.8	8.3
hba1c	sd (percent)	0.8	0.8
other male	n	11	12
other male	percent	61	71
sbp	mean (mmHg)	138.1	129.7
sbp	sd (mmHg)	17.7	12.9
uacr	median (mg/mmol)	1.53	0.94
uacr	q1 (mg/mmol)	1.24	0.42
uacr	q3 (mg/mmol)	3.17	2.96
weight	mean (kg)	95.8	99.2
weight	sd (kg)	17.7	15.2

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
8	A1	change	-0.6 percent	0.1			not stated; completers; R0013967:Results
8	A2	change	-0.8 percent	0.1			not stated; completers; R0013967:Results