Phase 2 N=659 Randomized Treatment

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT00881530 ↗

Enrolled (actual)

659

Serious AEs

7.9%

Results posted

Jun 2014

Primary outcome: Primary: Hypoglycaemic Events — 0.9; 1.8; 7.1; 2.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BI 10773 (Drug); Metformin (Drug); Sitagliptin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Hypoglycaemic Events	0.9; 1.8; 7.1; 2.4; 3.6; 5.4	—
PRIMARY Change From Baseline to Week 78 in Lipid Parameters	-0.13; 0.09; -0.24; 0.19; 0.13; -0.05	—
PRIMARY Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements	0.9; 0.9; 3.6; 0.6; 0.6; 1.8	—
SECONDARY Change From Baseline in HbA1c Over Time	-0.40; -0.57; -1.03; -0.36; -0.55; -0.75	—
SECONDARY Occurence of a Treat-to-target Response (HbA1c < 7.0%)	26.9; 25.0; 45.5; 24.1; 25.2; 35.2	—
SECONDARY Occurrence of a Treat-to-target Response (HbA1c < 6.5%)	3.8; 11.1; 16.4; 6.2; 6.7; 11.1	—
SECONDARY Occurrence of a Relative Efficacy Response	42.3; 50.9; 80.0; 41.4; 56.4; 63.0	—
SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) Over Time	-30.6; -35.8; -29.9; -25.7; -36.7; -32.6	—

Summary

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Eligibility Criteria

Inclusion criteria

patients completing one of double blind phase II trials 1245.9 or 1245.10
informed consent

Exclusion criteria

patients meeting withdrawal criteria of preceding trial
significant hepatic impairment
significant renal impairment with creatinine clearance < 50 ml/min
contraindication to Metformin for all patients treated with Metformin
premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
drug or alcohol abuse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00881530). 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.