Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01422876
First received: August 23, 2011
Last updated: April 1, 2015
Last verified: March 2015
  Purpose

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: high dose FDC
Drug: BI 10773 high dose
Drug: high dose FDC placebo
Drug: low dose FDC placebo
Drug: high dose BI 10773 placebo
Drug: low dose FDC
Drug: BI 10773 low dose
Drug: linagliptin
Drug: linagliptin placebo
Drug: BI 10773 low dose placebo
Drug: low dose BI 10773 placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.

  • Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.

  • Change From Baseline in Body Weight for Metformin Background Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in body weight for Metformin Background patients.

  • Change From Baseline in Body Weight for Treatment Naive Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in body weight for Treatment Naive patients.

  • Occurrence of Treat to Target Efficacy Response for Metformin Background Patients [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.

  • Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.


Enrollment: 1405
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773/linagliptin FDC (high dose)
Patients receive BI 10773/linagliptin FDC (high dose) once daily
Drug: high dose FDC
once daily
Drug: low dose FDC placebo
once daily
Drug: high dose BI 10773 placebo
once daily
Drug: BI 10773 low dose placebo
once daily
Drug: linagliptin placebo
once daily
Experimental: BI 10773/linagliptin FDC (low dose)
Patients receive BI 10773/linagliptin FDC (low dose) once daily
Drug: high dose FDC placebo
once daily
Drug: low dose FDC
once daily
Drug: high dose BI 10773 placebo
once daily
Drug: BI 10773 low dose placebo
once daily
Drug: linagliptin placebo
once daily
Active Comparator: BI 10773 (high dose)
Patients receive BI 10773 (high dose) once daily
Drug: BI 10773 high dose
once daily
Drug: high dose FDC placebo
once daily
Drug: low dose FDC placebo
once daily
Drug: low dose BI 10773 placebo
once daily
Drug: linagliptin placebo
once daily
Active Comparator: BI 10773 (low dose)
Patients receive BI 10773 (low dose) once daily
Drug: high dose FDC placebo
once daily
Drug: low dose FDC placebo
once daily
Drug: high dose BI 10773 placebo
once daily
Drug: BI 10773 low dose
low dose once daily
Drug: linagliptin placebo
once daily
Active Comparator: Linagliptin
Patients receive linagliptin once daily
Drug: low dose FDC placebo
once daily
Drug: high dose FDC placebo
once daily
Drug: linagliptin
once daily
Drug: high dose BI 10773 placebo
once daily
Drug: low dose BI 10773 placebo
once daily

  Eligibility

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

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
  3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Exclusion criteria:

  1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
  2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
  3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent
  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: NCT01422876

  Show 211 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
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: NCT01422876     History of Changes
Other Study ID Numbers: 1275.1, 2011-000383-10
Study First Received: August 23, 2011
Results First Received: January 15, 2015
Last Updated: April 1, 2015
Health Authority: Argentina: Ministry of Health
Australia: Human Research Ethics Committee
Brazil: National Committee of Ethics in Research
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Denmark: The Danish Health and Medicines Authority
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Lebanon: Ministry of Public Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Linagliptin
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 September 01, 2015