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: September 27, 2012
Last verified: September 2012
  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:
  • Primary endpoints are all safety relevant parameters: [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • incidence of adverse events; incidence of hypoglycemic events; use of rescue therapy; change from baseline in vital signs, body weight, waist circumference, lipid parameters to week 78; significant changes from baseline in clinical laboratory [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c from baseline (over time and after 78 weeks) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • percentage of patients treated to target HbA1c < 7.0 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (over time and after 78 weeks) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • occurence of an additional treat to target response, defined as an HbA1c after 78 weeks of <6.5% [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • occurence of a relative efficacy response (HbA1c lowered by >=0.5% after 78 weeks of treatment) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

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
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

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
Last Updated: September 27, 2012
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014