Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes

A Phase IIIb Randomised, Double-blind, Active-controlled, Parallel Group, Efficacy and Safety Study of Once Daily Oral Administration of Empagliflozin 25 mg Compared to Sitagliptin 100 mg During 52 Weeks in Type 2 Diabetes Mellitus Patients Who Are Treatment-naïve or on Treatment With Metformin With Insufficient Glycaemic Control

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01984606

Enrollment

Registered

2013-11-14

Start date

2015-01-31

Completion date

2017-02-28

Last updated

2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.

Interventions

DRUGEmpagliflozin

Empagliflozin once daily

DRUGPlacebo

Placebo matching empagliflozin

DRUGSitagliptin

Sitagliptin once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion criteria: * Diagnosis of type 2 diabetes mellitus. * Male and female patients on diet and exercise regimen who are: * Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation. or * Pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. Minimum dose for metformin: \>=1500 mg/day or maximum tolerated dose or maximum dose according to local label. * HbA1c of \>= 7.5 % and \<= 10.5 % at Visit 1 and 3. * Age \>= 18 yrs.

Exclusion criteria

* Uncontrolled hyperglycaemia with a glucose level \>270 mg/dL (\>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in. * Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients). * Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin). * Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent. * Indication of liver disease. * Moderate to severe renal impairment. * Bariatric surgery within the past two years. * Treatment with anti-obesity drugs 3 months prior to informed consent. * Current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.

Design outcomes

Primary

Measure	Time frame
The change from baseline in HbA1c after 52 weeks of treatment.	Baseline and week 52

Secondary

Measure	Time frame
The change in bodyweight (kg) from baseline after 52 weeks of treatment	Baseline and week 52
The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment	Baseline and week 52
The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment	Week 24 and week 52
The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment	Baseline and week 52

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026