Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

Study Overview
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Brief Summary
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The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Official Title
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A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: BI 10773
* Drug: Metformin
* Drug: BI 10773
* Drug: Sitagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: patients completing one of double blind phase II trials 1245.9 or 1245.10 informed consent Exclusion criteria: patients meeting withdrawal criteria of preceding trial significant hepatic impairment significant renal impairment with creatinine clearance < 50 ml/min contraindication to Metformin for all patients treated with Metformin premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control drug or alcohol abuse

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin<br>100 mg | Drug: Sitagliptin<br>* open label comparator<br>|
| Active Comparator: Metformin<br>2000 mg | Drug: Metformin<br>* open label comparator<br>|
| Experimental: BI 10773 X mg<br>lower dose | Drug: BI 10773<br>* BI 10773 low dose once daily<br>|
| Experimental: BI 10773 Y mg<br>higher dose | Drug: BI 10773<br>* BI 10773 high dose once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemic Events | Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions | 78 weeks plus 1 week of follow-up | 
| Change From Baseline to Week 78 in Lipid Parameters | Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride) | Weeks 1 and 78 | 
| Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events. | 78 weeks plus 1 week of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c Over Time | Baseline source: before first intake of active treatment (preceding trial or Open label extension) | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | 
| Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | 
| Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | 
| Occurrence of a Relative Efficacy Response | Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time) | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | 
| Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Baseline source: before first intake of active treatment (preceding trial or Open label extension) | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 |