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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Empagliflozin

Placebo

Sitagliptin

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Empagliflozin

Sitagliptin

Arm Description

Empagliflozin once daily

Sitagliptin once daily

Outcomes

Primary Outcome Measures

The change from baseline in HbA1c after 52 weeks of treatment.

Secondary Outcome Measures

The change in bodyweight (kg) from baseline after 52 weeks of treatment

The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment

The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment

The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment

Full Information

NCT ID

NCT01984606

First Posted

November 8, 2013

Last Updated

October 24, 2014

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01984606

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Withdrawn

Study Start Date

January 2015 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Empagliflozin

Arm Type

Experimental

Arm Description

Empagliflozin once daily

Arm Title

Sitagliptin

Arm Type

Active Comparator

Arm Description

Sitagliptin once daily

Intervention Type

Drug

Intervention Name(s)

Empagliflozin

Intervention Description

Empagliflozin once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching empagliflozin

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Intervention Description

Sitagliptin once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching sitagliptin

Primary Outcome Measure Information:

Title

The change from baseline in HbA1c after 52 weeks of treatment.

Time Frame

Baseline and week 52

Secondary Outcome Measure Information:

Title

The change in bodyweight (kg) from baseline after 52 weeks of treatment

Time Frame

Baseline and week 52

Title

The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment

Time Frame

Baseline and week 52

Title

The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment

Time Frame

Week 24 and week 52

Title

The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment

Time Frame

Baseline and week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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