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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773; Drug: Metformin; Drug: Sitagliptin

• Registration Number: NCT00881530
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Primary Completion: 2011-05
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-16
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 10773 X mg	BI 10773	lower dose
BI 10773 Y mg	BI 10773	higher dose
Metformin	Metformin	2000 mg
Sitagliptin	Sitagliptin	100 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 78 in Lipid Parameters	Weeks 1 and 78	Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements	78 weeks plus 1 week of follow-up	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.
Hypoglycaemic Events	78 weeks plus 1 week of follow-up	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

Secondary Outcome Measures

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

Trial Locations

Locations (137)

1245.24.101001 Boehringer Ingelheim Investigational Site; 🇺🇸 Mission Viejo, California, United States

1245.24.101028 Boehringer Ingelheim Investigational Site; 🇺🇸 Spring Valley, California, United States

1245.24.101027 Boehringer Ingelheim Investigational Site; 🇺🇸 Walnut Creek, California, United States

1245.24.101004 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwarter, Florida, United States

1245.24.101005 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1245.24.101024 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Cloud, Florida, United States

1245.24.101014 Boehringer Ingelheim Investigational Site; 🇺🇸 Roswell, Georgia, United States

1245.24.101016 Boehringer Ingelheim Investigational Site; 🇺🇸 Staten Island, New York, United States

1245.24.101006 Boehringer Ingelheim Investigational Site; 🇺🇸 Wadsworth, Ohio, United States

1245.24.101023 Boehringer Ingelheim Investigational Site; 🇺🇸 Norristown, Pennsylvania, United States

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