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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00881530
First received: April 14, 2009
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: Metformin
Drug: Sitagliptin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Hypoglycaemic Events [ Time Frame: 78 weeks plus 1 week of follow-up ] [ Designated as safety issue: No ]

    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

  • Change From Baseline to Week 78 in Lipid Parameters [ Time Frame: Weeks 1 and 78 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 78 weeks plus 1 week of follow-up ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in HbA1c Over Time [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ] [ Designated as safety issue: No ]
    Baseline source: before first intake of active treatment (preceding trial or Open label extension)

  • Occurence of a Treat-to-target Response (HbA1c < 7.0%) [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ] [ Designated as safety issue: No ]
    Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time

  • Occurrence of a Treat-to-target Response (HbA1c < 6.5%) [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ] [ Designated as safety issue: No ]
    Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time

  • Occurrence of a Relative Efficacy Response [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78 ] [ Designated as safety issue: No ]
    Baseline source: before first intake of active treatment (preceding trial or Open label extension)


Enrollment: 660
Study Start Date: March 2009
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881530

  Show 137 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00881530     History of Changes
Other Study ID Numbers: 1245.24, 2008-007938-21
Study First Received: April 14, 2009
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Korea: Food and Drug Administration
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Norway: Norwegian Medicines Agency
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014