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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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:

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

Exclusion criteria:

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.
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.
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.
Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
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.
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.
Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
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 Pharmaceuticals

Eli Lilly and Company

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
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 13, 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 June 17, 2013