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

Study Overview
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: Placebo
* Drug: Sitagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin<br>Empagliflozin once daily | Drug: Empagliflozin<br>* Empagliflozin once daily<br>Drug: Placebo<br>* Placebo matching empagliflozin<br>|
| Active Comparator: Sitagliptin<br>Sitagliptin once daily | Drug: Sitagliptin<br>* Sitagliptin once daily<br>Drug: Placebo<br>* Placebo matching sitagliptin<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |