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

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ClinicalTrials.gov Identifier: NCT00881530
Recruitment Status : Completed
First Posted : April 15, 2009
Results First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: BI 10773 Drug: Metformin Drug: Sitagliptin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2009
Actual Primary Completion Date : May 2011

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sitagliptin
100 mg
 Drug: Sitagliptin
open label comparator
Active Comparator: Metformin
2000 mg
 Drug: Metformin
open label comparator
Experimental: BI 10773 X mg
lower dose
 Drug: BI 10773
BI 10773 low dose once daily
Experimental: BI 10773 Y mg
higher dose
 Drug: BI 10773
BI 10773 high dose once daily


Outcome Measures
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Primary Outcome Measures :
  1. Hypoglycaemic Events [ Time Frame: 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

  2. Change From Baseline to Week 78 in Lipid Parameters [ Time Frame: 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)

  3. Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c Over Time [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ]
    Baseline source: before first intake of active treatment (preceding trial or Open label extension)

  2. Occurence of a Treat-to-target Response (HbA1c < 7.0%) [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ]
    Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time

  3. Occurrence of a Treat-to-target Response (HbA1c < 6.5%) [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ]
    Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time

  4. Occurrence of a Relative Efficacy Response [ Time Frame: 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)

  5. Change From Baseline in Fasting Plasma Glucose (FPG) Over Time [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ]
    Baseline source: before first intake of active treatment (preceding trial or Open label extension)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881530


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00881530    
Other Study ID Numbers: 1245.24
2008-007938-21 ( EudraCT Number: EudraCT )
First Posted: April 15, 2009    Key Record Dates
Results First Posted: June 16, 2014
Last Update Posted: June 16, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Empagliflozin
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors