Phase 1 N=23 Randomized Treatment

Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT01276288 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline — -0.031; -0.055; -0.071; 0.143 ml/min

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: BI 10773 (Drug); hydrochlorothiazide (Drug); torasemide (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline	-0.031; -0.055; -0.071; 0.143; -0.004; -0.129	—
PRIMARY Change in Urinary Excretion in a 24-hour Period of Sodium, Potassium, Magnesium, Chloride, Calcium, Phosphate, Creatinine, Uric Acid, Glucose From Baseline	-4.300; -11.700; -13.700; 28.900; 1.200; -16.300	—
PRIMARY Change in Urinary Excretion in a 24-hour Period of N-terminal Telopeptide (NTx) From Baseline	6.010; 0.730; 2.030; 1.380; 3.900	—
PRIMARY Change in Serum Osmolality From Baseline	3.950; -7.500; -5.500; -2.200; 10.500	—
PRIMARY Change in Serum Concentration of Sodium, Potassium, Magnesium, Calcium, Chloride, Phosphate, Glucose and Urea From Baseline	1.500; -0.500; 0.200; -0.100; 1.600; -0.170	—
PRIMARY Change in Serum Concentration of Creatinine and Uric Acid From Baseline	2.175; -0.340; -2.180; 6.280; 3.570; -64.950	—
PRIMARY Change in Serum Concentration of Alkaline Phosphatase (ALP) From Baseline	2.750; 3.000; 2.400; 6.500; 5.800	—
PRIMARY Change in Serum Concentration of Renin, Intact Parathyroid Hormone (iPTH) and 1,25-dihydroxyvitamin D From Baseline	-0.960; 16.150; 2.550; 32.760; 17.050; 8.265	—
PRIMARY Change in Serum Concentration of Aldosterone From Baseline	-0.018; 0.099; 0.023; 0.124; 0.123	—
PRIMARY Change in Serum Concentration of Fibroblast Growth Factor-23 (FGF- 23) From Baseline	50.305; 29.050; -0.680; 109.860; 13.820	—
PRIMARY Change in Urea Concentration in Urine	-1.515; 67.570; 35.710; 11.780; 48.690	—
PRIMARY Change in Urine pH From Baseline	-0.132; -0.452; -0.147; -0.448; 0.130	—
PRIMARY Change in Urine Osmolality From Baseline	223.15; -3.900; -5.800; 217.700; 330.400	—
PRIMARY Changes in Bicarbonate Concentrations of Calcium, Bicarbonate Ions and Base Excess in Capillary or Arterialised Blood From Baseline	-1.090; 2.020; -0.400; 1.860; -1.590; -0.049	—
PRIMARY Change in pH in Capillary or Arterialised Blood From Baseline	-0.006; 0.003; -0.002; 0.008; -0.005	—
PRIMARY Change in Body Weight From Baseline	-1.365; -1.040; -0.380; -2.030; -1.750	—
PRIMARY Change in Urinary Weight From Baseline	134.700; -55.300; -39.000; 429.000; 353.200	—
PRIMARY The Change in Micturition Frequency From the Baseline	1.600	—
PRIMARY The Change in Total Muscle Sympathetic Nerve Activity (MSNA) From Off- Treatment	0.241	—
PRIMARY Urinary Sodium Excretion Over 24-hour run-in Periods	198.50; 211.10; 217.90; 174.35; 183.30; 178.70	—
SECONDARY Area Under the Concentration-time Curve of Empa in Plasma (AUCτ,ss)	4990; 5570; 5260	0.0092 sig
SECONDARY Maximum Measured Concentration of Empa in Plasma (Cmax, ss)	939; 1030; 949	0.0199 sig
SECONDARY Area Under the Concentration-time Curve of HCT in Plasma (AUCτ,ss)	1040; 1000	0.0008 sig
SECONDARY Maximum Measured Concentration of HCT in Plasma (Cmax, ss)	203; 205	0.0114 sig
SECONDARY Area Under the Concentration-time Curve of TOR in Plasma (AUCτ,ss)	1320; 1340; 74.8; 40.5; 78.1; 41.8	<0.0001 sig
SECONDARY Maximum Measured Concentration of TOR in Plasma (Cmax, ss)	710; 741; 42.6; 8.58; 43.8; 8.79	0.0066 sig
SECONDARY Number of Subjects With Clinical Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests, 12-lead Resting Electrocardiogram (ECG), Physical Examination and Assessment of Tolerability by the Investigator	1; 0; 0; 0; 0	—

Summary

The primary objective of the study is to investigate the effect of BI 10773, hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be assessed.

Eligibility Criteria

Inclusion criteria

male and female patients of type 2 diabetes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01276288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.