Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01289990
First received: January 31, 2011
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: Placebo
Drug: Sitagliptin 100mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes from baseline in clinical laboratory values, changes from baseline of Albumin/creatinine ratio and use of rescue therapy after 52, 76 weeks of treatment and at end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
  • To investigate the long-term safety and tolerability of BI 10773. [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
  • Incidence and intensity of adverse events, hypoglycaemic events, protocol-specified significant adverse events, cardiovascular events (Clinical Event Committee adjudication results) after 52, 76 weeks of treatment and at end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess efficacy of BI 10773 and for patients from 1245.20 sitagliptin for minimum 76 weeks compared to placebo as monotherapy or placebo on a background of pioglitazone or placebo on a background of metformin with or without sulfonylurea. [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
  • The HbA1c, body weight (kg), waist circumference and fasting plasma glucose changes from baseline after 52, 76 weeks of treatment and to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
  • Composite endpoint of the following conditions after 52, 76 weeks of treatment and to end of trial change from baseline in (all three fulfilled): - HbA1c > 0.5% - systolic blood pressure > 3 mmHg - weight >2% [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure: Change from baseline after 52, 76 weeks of treatment and to end of trial For patients rolling over from 1245.20: - Change from baseline in biomarkers of insulin sensitivity and secretion to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]

Enrollment: 1869
Study Start Date: February 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low (drug naive)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching Sitagliptin
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 high (drug naive)
BI 10773 tablets once daily
Drug: Placebo
Placebo matching Sitagliptin
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (drug naive)
Placebo tablets matching BI 10773 / Sitagliptin once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching Sitagliptin
Drug: Placebo
Placebo matching BI 10773 high dose
Active Comparator: Sitagliptin 100mg (drug naive)
Sitagliptin once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Sitagliptin 100mg
Sitagliptin once daily
Experimental: BI 10773 low (pioglitazone)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 high (pioglitazone)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (pioglitazone)
Placebo tablets matching BI 10773 once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 low (metformin)
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: BI 10773
BI 10773 tablets once daily
Experimental: BI 10773 high (metformin)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (metformin)
Placebo tablets matching BI 10773 once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 low (metformin+sulfonylurea)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 high (metformin+sulfonylurea)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (metformin+sulfonylurea)
Placebo tablets matching BI 10773
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
  2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

  1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
  2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
  3. Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
  4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
  5. Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
  6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
  7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
  8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289990

  Show 243 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01289990     History of Changes
Other Study ID Numbers: 1245.31, 2010-022718-17
Study First Received: January 31, 2011
Last Updated: June 26, 2013
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Sanitary Risks Protection
Philippines: Department of Health
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Switzerland: Swissmedic
Taiwan:
Turkey: Ministry 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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014