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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01984606
• Other study ID #: 1245.22
• Secondary ID: 2013-000060-29
• Status: Withdrawn
• Phase: Phase 3
• First received: November 8, 2013
• Last updated: October 24, 2014
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Empagliflozin
Empagliflozin once daily
• Placebo
Placebo matching empagliflozin
• Sitagliptin
Sitagliptin once daily
• Placebo
Placebo matching sitagliptin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in HbA1c after 52 weeks of treatment.		Baseline and week 52	No
Secondary	The change in bodyweight (kg) from baseline after 52 weeks of treatment		Baseline and week 52	No
Secondary	The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment		Baseline and week 52	No
Secondary	The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment		Week 24 and week 52	No
Secondary	The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment		Baseline and week 52	No