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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Empagliflozin; Drug: Placebo; Drug: Placebo; Drug: Sitagliptin

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empagliflozin; Empagliflozin once daily	Drug: Empagliflozin; Empagliflozin once daily; Drug: Placebo; Placebo matching empagliflozin; Drug: Placebo; Placebo matching sitagliptin
Active Comparator: Sitagliptin; Sitagliptin once daily	Drug: Placebo; Placebo matching empagliflozin; Drug: Placebo; Placebo matching sitagliptin; Drug: Sitagliptin; Sitagliptin once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Empagliflozin; Sitagliptin Phosphate
• Other Study ID Numbers: 1245.22; 2013-000060-29 (EudraCT Number: EudraCT)