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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Empagliflozin

Empagliflozin once daily

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

Empagliflozin once daily

Placebo

Intervention Type DRUG

Placebo matching empagliflozin

Sitagliptin

Sitagliptin once daily

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Sitagliptin once daily

Placebo

Intervention Type DRUG

Placebo matching sitagliptin

Interventions

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Empagliflozin

Empagliflozin once daily

Intervention Type DRUG

Placebo

Placebo matching empagliflozin

Intervention Type DRUG

Sitagliptin

Sitagliptin once daily

Intervention Type DRUG

Placebo

Placebo matching sitagliptin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No