Phase 3 N=2,705 Double-blind Treatment

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT01289990 ↗

Enrolled (actual)

2,705

Serious AEs

9.8%

Results posted

Jul 2014

Primary outcome: Primary: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment — -0.70; -0.82; 0.09; -0.58 % of HbA1c — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BI 10773 (Drug); Placebo (Drug); Sitagliptin 100mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment	-0.70; -0.82; 0.09; -0.58; -0.63; -0.71	<0.0001 sig
PRIMARY Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment	-0.65; -0.76; 0.13; -0.53; -0.61; -0.70	<0.0001 sig
SECONDARY HbA1c (%) Changes From Baseline After 76 Weeks of Treatment	-0.70; -0.77; 0.13; -0.48; -0.67; -0.77	<0.0001 sig
SECONDARY Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	-4.9; -4.5; -1.6; -0.2; -1.8; -3.3	<0.0001 sig
SECONDARY Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	-4.1; -4.2; -0.7; -0.3; -1.7; -3.4	0.0025 sig
SECONDARY Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	-1.3; -1.9; -0.2; -0.3; -1.6; -2.2	0.1058
SECONDARY Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	-1.6; -1.6; -0.6; -0.1; -1.3; -2.0	0.1568
SECONDARY Body Weight (kg) Change From Baseline After 52 Weeks of Treatment	-2.70; -2.61; -0.48; 0.14; -1.50; -1.40	<0.0001 sig
SECONDARY Body Weight (kg) Change From Baseline After 76 Weeks of Treatment	-2.24; -2.45; -0.43; 0.10; -1.47; -1.21	<0.0001 sig
SECONDARY Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment	-2.0; -1.7; 0.1; 0.4; -1.5; -1.1	0.0001 sig
SECONDARY Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment	-1.5; -1.6; 0.1; 0.5; -1.4; -0.9	0.0028 sig
SECONDARY Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment	-18.9; -23.9; 13.3; -3.9; -16.7; -20.7	<0.0001 sig
SECONDARY Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment	-17.2; -20.4; 14.4; -1.8; -13.9; -18.0	<0.0001 sig

Summary

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Eligibility Criteria

Inclusion criteria

Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria

Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01289990). 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.