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Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

NCT ID: NCT01159600

Last Updated: 2014-06-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

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

NCT01422876

Diabetes Mellitus, Type 2
COMPLETED PHASE3

Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

NCT01011868

Diabetes Mellitus, Type 2
COMPLETED PHASE2

Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 10773 Arm 2

BI 10773 once daily high dose

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily high dose

Placebo identical to BI 10773 low dose

Intervention Type DRUG

Placebo tablets matching BI 10773 low dose

Placebo

Placebo matching BI 10773

Group Type PLACEBO_COMPARATOR

Placebo identical to BI 10773 low dose

Intervention Type DRUG

Placebo tablets matching BI 10773 low dose

Placebo identical to BI 10773 high dose

Intervention Type DRUG

Placebo tablets matching BI 10773 high dose

BI 10773 open-label

BI 10773 once daily high dose open label

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily high dose open label

BI 10773 Arm 1

BI 10773 once daily low dose

Group Type EXPERIMENTAL

Placebo identical to BI 10773 high dose

Intervention Type DRUG

Placebo tablets matching BI 10773 high dose

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily low dose

Interventions

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Placebo identical to BI 10773 high dose

Placebo tablets matching BI 10773 high dose

Intervention Type DRUG

Placebo identical to BI 10773 low dose

Placebo tablets matching BI 10773 low dose

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily high dose open label

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily high dose

Intervention Type DRUG

Placebo identical to BI 10773 low dose

Placebo tablets matching BI 10773 low dose

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily low dose

Intervention Type DRUG

Placebo identical to BI 10773 high dose

Placebo tablets matching BI 10773 high dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.

Minimum dose for metformin: \> or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: \> or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label
3. HbA1c of \> or = 7.0% and \< or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of \> 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
4. Age\> or = 18
5. Body Mass Index (BM)I \< or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
6. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

1. Uncontrolled hyperglycaemia 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 randomisation except those mentioned in inclusion criterion 2
3. Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
5. Impaired renal function, defined as eGFR\<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
9. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Typ 2 Diabetes
12. Pre-menopausal women (last menstruation ¿ 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 (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
13. 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
14. Participation in another trial with an investigational drug within 30 days prior to informed consent
15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.23.10145 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1245.23.10046 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Site Status

1245.23.10095 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Site Status

1245.23.10109 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Site Status

1245.23.10074 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1245.23.10149 Boehringer Ingelheim Investigational Site

Rancho Cucamonga, California, United States

Site Status

1245.23.10127 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

1245.23.10042 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

1245.23.10133 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Site Status

1245.23.10080 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

1245.23.10001 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1245.23.10159 Boehringer Ingelheim Investigational Site

Des Moines, Iowa, United States

Site Status

1245.23.10117 Boehringer Ingelheim Investigational Site

Arkansas City, Kansas, United States

Site Status

1245.23.10157 Boehringer Ingelheim Investigational Site

Newton, Kansas, United States

Site Status

1245.23.10148 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

1245.23.10034 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

1245.23.10123 Boehringer Ingelheim Investigational Site

Smithtown, New York, United States

Site Status

1245.23.10120 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1245.23.10031 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1245.23.10158 Boehringer Ingelheim Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

1245.23.10015 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Site Status

1245.23.10156 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1245.23.10153 Boehringer Ingelheim Investigational Site

Hurst, Texas, United States

Site Status

1245.23.10143 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1245.23.10106 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1245.23.20032 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1245.23.20023 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1245.23.20028 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1245.23.20033 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

1245.23.20024 Boehringer Ingelheim Investigational Site

Paradise, Newfoundland and Labrador, Canada

Site Status

1245.23.20031 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1245.23.20026 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

1245.23.20001 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Site Status

1245.23.20022 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Site Status

1245.23.20035 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Site Status

1245.23.20030 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

Site Status

1245.23.20037 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1245.23.20029 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1245.23.20003 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

Site Status

1245.23.20040 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Site Status

1245.23.20034 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1245.23.20039 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1245.23.20027 Boehringer Ingelheim Investigational Site

Laval, Quebec, Canada

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1245.23.20025 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1245.23.20038 Boehringer Ingelheim Investigational Site

Saint-Laurent, Quebec, Canada

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1245.23.20036 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1245.23.86031 Boehringer Ingelheim Investigational Site

Beijing, , China

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1245.23.86032 Boehringer Ingelheim Investigational Site

Beijing, , China

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1245.23.86033 Boehringer Ingelheim Investigational Site

Beijing, , China

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1245.23.86034 Boehringer Ingelheim Investigational Site

Beijing, , China

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1245.23.86035 Boehringer Ingelheim Investigational Site

Beijing, , China

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1245.23.86048 Boehringer Ingelheim Investigational Site

Chengdu, , China

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1245.23.86058 Boehringer Ingelheim Investigational Site

Chongqing, , China

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1245.23.86038 Boehringer Ingelheim Investigational Site

Dalian, , China

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1245.23.86002 Boehringer Ingelheim Investigational Site

Guangzhou, , China

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1245.23.86052 Boehringer Ingelheim Investigational Site

Guangzhou, , China

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1245.23.86037 Boehringer Ingelheim Investigational Site

Haerbin, , China

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1245.23.86049 Boehringer Ingelheim Investigational Site

Jinan, , China

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1245.23.86053 Boehringer Ingelheim Investigational Site

Jinan, , China

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1245.23.86042 Boehringer Ingelheim Investigational Site

Nanjing, , China

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1245.23.86043 Boehringer Ingelheim Investigational Site

Nanjing, , China

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1245.23.86055 Boehringer Ingelheim Investigational Site

Nanning, , China

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1245.23.86056 Boehringer Ingelheim Investigational Site

Nanning, , China

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1245.23.86039 Boehringer Ingelheim Investigational Site

Shanghai, , China

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1245.23.86040 Boehringer Ingelheim Investigational Site

Shanghai, , China

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1245.23.86054 Boehringer Ingelheim Investigational Site

Shantou, , China

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1245.23.86057 Boehringer Ingelheim Investigational Site

Shenyang, , China

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1245.23.86045 Boehringer Ingelheim Investigational Site

Shijiazhuang, , China

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1245.23.86013 Boehringer Ingelheim Investigational Site

Suzhou, , China

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1245.23.86036 Boehringer Ingelheim Investigational Site

Tianjin, , China

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1245.23.86041 Boehringer Ingelheim Investigational Site

Xi'an, , China

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1245.23.86051 Boehringer Ingelheim Investigational Site

Zhenjiang, , China

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1245.23.33015 Boehringer Ingelheim Investigational Site

Arras, , France

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1245.23.33008 Boehringer Ingelheim Investigational Site

Bersée, , France

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1245.23.33020 Boehringer Ingelheim Investigational Site

Bischheim, , France

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1245.23.33002 Boehringer Ingelheim Investigational Site

Bondy, , France

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1245.23.33016 Boehringer Ingelheim Investigational Site

Bruay-la-Buissière, , France

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1245.23.33001 Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, , France

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1245.23.33010 Boehringer Ingelheim Investigational Site

Croix, , France

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1245.23.33009 Boehringer Ingelheim Investigational Site

Hautmont, , France

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1245.23.33003 Boehringer Ingelheim Investigational Site

La Rochelle, , France

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1245.23.33045 Boehringer Ingelheim Investigational Site

Marseille, , France

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1245.23.33014 Boehringer Ingelheim Investigational Site

Mundolsheim, , France

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1245.23.33004 Boehringer Ingelheim Investigational Site

Narbonne, , France

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1245.23.33012 Boehringer Ingelheim Investigational Site

Schiltigheim, , France

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1245.23.33013 Boehringer Ingelheim Investigational Site

Strasbourg, , France

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1245.23.33019 Boehringer Ingelheim Investigational Site

Strasbourg, , France

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1245.23.33007 Boehringer Ingelheim Investigational Site

Vieux-Condé, , France

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1245.23.33018 Boehringer Ingelheim Investigational Site

Wattrelos, , France

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1245.23.49001 Boehringer Ingelheim Investigational Site

Dormagen, , Germany

Site Status

1245.23.49009 Boehringer Ingelheim Investigational Site

Flörsheim, , Germany

Site Status

1245.23.49004 Boehringer Ingelheim Investigational Site

Hatten, , Germany

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1245.23.49007 Boehringer Ingelheim Investigational Site

Künzing, , Germany

Site Status

1245.23.49002 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

Site Status

1245.23.49008 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1245.23.49010 Boehringer Ingelheim Investigational Site

Rednitzhembach, , Germany

Site Status

1245.23.49006 Boehringer Ingelheim Investigational Site

Rehburg-Loccum, , Germany

Site Status

1245.23.49011 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

1245.23.49005 Boehringer Ingelheim Investigational Site

Saarbrücken, , Germany

Site Status

1245.23.49003 Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

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1245.23.91101 Boehringer Ingelheim Investigational Site

Coimbatore, , India

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1245.23.91104 Boehringer Ingelheim Investigational Site

Indore, , India

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1245.23.91103 Boehringer Ingelheim Investigational Site

Maharashtra, , India

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1245.23.91102 Boehringer Ingelheim Investigational Site

Nagpur, , India

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1245.23.91105 Boehringer Ingelheim Investigational Site

Pune, , India

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1245.23.52003 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

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1245.23.52004 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

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1245.23.52001 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1245.23.52002 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1245.23.74005 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1245.23.74002 Boehringer Ingelheim Investigational Site

Lučenec, , Slovakia

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1245.23.74006 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

1245.23.74014 Boehringer Ingelheim Investigational Site

Nové Zámky, , Slovakia

Site Status

1245.23.74001 Boehringer Ingelheim Investigational Site

Považská Bystrica, , Slovakia

Site Status

1245.23.74004 Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

Site Status

1245.23.74003 Boehringer Ingelheim Investigational Site

Trebišov, , Slovakia

Site Status

1245.23.38003 Boehringer Ingelheim Investigational Site

Celje, , Slovenia

Site Status

1245.23.38002 Boehringer Ingelheim Investigational Site

Koper, , Slovenia

Site Status

1245.23.38001 Boehringer Ingelheim Investigational Site

Maribor, , Slovenia

Site Status

1245.23.82012 Boehringer Ingelheim Investigational Site

Anyang, , South Korea

Site Status

1245.23.82004 Boehringer Ingelheim Investigational Site

Busan, , South Korea

Site Status

1245.23.82011 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

Site Status

1245.23.82009 Boehringer Ingelheim Investigational Site

Ilsan, , South Korea

Site Status

1245.23.82001 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

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1245.23.82006 Boehringer Ingelheim Investigational Site

Jeonju, , South Korea

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1245.23.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.23.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1245.23.82008 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.23.82010 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.23.82014 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.23.82002 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1245.23.82003 Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

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1245.23.88010 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

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1245.23.88011 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

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1245.23.88012 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

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1245.23.88013 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1245.23.88009 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

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1245.23.88014 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

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1245.23.88006 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1245.23.88007 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1245.23.88021 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1245.23.88008 Boehringer Ingelheim Investigational Site

Taoyuan, , Taiwan

Site Status

1245.23.90003 Boehringer Ingelheim Investigational Site

Erzurum, , Turkey (Türkiye)

Site Status

1245.23.90001 Boehringer Ingelheim Investigational Site

Gaziantep, , Turkey (Türkiye)

Site Status

1245.23.90002 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1245.23.90006 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1245.23.90007 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1245.23.90004 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

Countries

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United States Canada China France Germany India Mexico Slovakia Slovenia South Korea Taiwan Turkey (Türkiye)

References

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Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Reference Type DERIVED
PMID: 38770818 (View on PubMed)

Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

Reference Type DERIVED
PMID: 35472672 (View on PubMed)

Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.

Reference Type DERIVED
PMID: 33084149 (View on PubMed)

Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

Reference Type DERIVED
PMID: 27316632 (View on PubMed)

Haring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG METSU Trial Investigators. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013 Nov;36(11):3396-404. doi: 10.2337/dc12-2673. Epub 2013 Aug 20.

Reference Type DERIVED
PMID: 23963895 (View on PubMed)

Other Identifiers

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2009-016258-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.23

Identifier Type: -

Identifier Source: org_study_id

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Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin
NCT02150824 COMPLETED PHASE2
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
NCT02102932 COMPLETED PHASE1
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female
NCT02266472 COMPLETED PHASE1
Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together
NCT01811953 COMPLETED PHASE1
Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets
NCT06450262 COMPLETED PHASE1
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
NCT01844531 COMPLETED PHASE1
Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes
NCT02537470 COMPLETED PHASE2
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
NCT03629054 COMPLETED PHASE1
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
NCT01215097 COMPLETED PHASE3
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
NCT01068717 COMPLETED PHASE1
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
NCT01975220 COMPLETED PHASE1
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
NCT02028767 COMPLETED PHASE1
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects
NCT02230995 COMPLETED PHASE1
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
NCT03259490 COMPLETED PHASE1