Phase 3 N=1,549 Randomized Double-blind Treatment

Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT01167881 ↗

Enrolled (actual)

1,549

Serious AEs

20.3%

Results posted

Aug 2014

Primary outcome: Primary: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. — -0.66; -0.55 percentage of HbA1c — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BI 10773 (Drug); Glimepiride (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.	-0.66; -0.55	<0.0001 sig
SECONDARY The Change in Body Weight From Baseline After 104 Weeks of Treatment.	-3.11; 1.33	<0.0001 sig
SECONDARY The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.	19; 189	<0.0001 sig
SECONDARY The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.	-3.1; 2.5	<0.0001 sig
SECONDARY The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.	-1.8; 0.9	<0.0001 sig
SECONDARY The Change From Baseline in HbA1c After 52 Weeks of Treatment.	-0.73; -0.66	<0.0001 sig
SECONDARY The Change in Body Weight From Baseline After 52 Weeks of Treatment.	-3.21; 1.59	<0.0001 sig
SECONDARY The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.	12; 159	<0.0001 sig
SECONDARY The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.	-3.6; 2.2	<0.0001 sig
SECONDARY The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.	-1.9; 1.0	<0.0001 sig

Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Eligibility Criteria

Inclusion criteria

Diagnosis typ 2 diabetes mellitus
Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
18 years or more
BMI equal or less than 45Kg/m2

Exclusion criteria

Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
Indication of liver disease
Moderate to severe renal impairment
Bariatric surgery within past 2 years
Medical history of cancer or treatment for cancer within last 5 years
Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
Contraindications hypersensitivity to concomitant drugs
Treatment with anti-obesity drugs

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01167881). 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.