Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01734785 |
|
Recruitment Status
:
Completed
First Posted
: November 28, 2012
Results First Posted
: April 18, 2016
Last Update Posted
: July 11, 2016
|
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
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Brief Summary:
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: Linagliptin Drug: Empagliflozin + Linagliptin Drug: Empaglifozin placebo + Linagliptin placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 607 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy. |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | March 2015 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Linagliptin
5 mg once daily
|
Drug: Linagliptin
tablet
Drug: Empaglifozin placebo + Linagliptin placebo
Matching Empaglifozin + Linagliptin low dose
|
|
Experimental: Empaglifozin + Linagliptin low dose
1 tablet once daily
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Drug: Empagliflozin + Linagliptin
Fixed dose combination.
Drug: Empagliflozin + Linagliptin
Fixed dose combination
|
|
Experimental: Empagliflozin + Linagliptin high dose
1 tablet once daily
|
Drug: Empagliflozin + Linagliptin
Fixed dose combination
Drug: Empagliflozin + Linagliptin
Fixed dose combination.
|
Primary Outcome Measures
:
- HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment [ Time Frame: Baseline and 24 weeks ]Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
Secondary Outcome Measures
:
- Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment. [ Time Frame: Baseline and 24 weeks ]Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.
- Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment [ Time Frame: Baseline and 24 weeks ]Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus.
- Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
- HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
- Age 18 years or more at screening.
- Body Mass Index lower or equal to 45 kg/m2 at screening visit.
- Signed and dated written informed consent.
Exclusion criteria:
- Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
- Use of any other antidiabetic drug (except metformin background therapy).
- Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
- Indication of liver disease.
- Impaired renal function.
- Gastrointestinal surgery.
- Treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
- Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734785
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Locations
| United States, Alabama | |
| 1275.9.01013 Boehringer Ingelheim Investigational Site | |
| Gulf Shores, Alabama, United States | |
| United States, California | |
| 1275.9.01009 Boehringer Ingelheim Investigational Site | |
| Norwalk, California, United States | |
| 1275.9.01015 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 1275.9.01017 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| United States, Colorado | |
| 1275.9.01011 Boehringer Ingelheim Investigational Site | |
| Northglenn, Colorado, United States | |
| United States, Florida | |
| 1275.9.01010 Boehringer Ingelheim Investigational Site | |
| Coral Gables, Florida, United States | |
| 1275.9.01004 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 1275.9.01006 Boehringer Ingelheim Investigational Site | |
| Oldsmar, Florida, United States | |
| 1275.9.01001 Boehringer Ingelheim Investigational Site | |
| Palm Coast, Florida, United States | |
| 1275.9.01027 Boehringer Ingelheim Investigational Site | |
| Port Orange, Florida, United States | |
| United States, Georgia | |
| 1275.9.01029 Boehringer Ingelheim Investigational Site | |
| Blue Ridge, Georgia, United States | |
| 1275.9.01003 Boehringer Ingelheim Investigational Site | |
| Marietta, Georgia, United States | |
| 1275.9.01022 Boehringer Ingelheim Investigational Site | |
| Savannah, Georgia, United States | |
| United States, Illinois | |
| 1275.9.01031 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| 1275.9.01019 Boehringer Ingelheim Investigational Site | |
| Methuen, Massachusetts, United States | |
| United States, Michigan | |
| 1275.9.01024 Boehringer Ingelheim Investigational Site | |
| Troy, Michigan, United States | |
| United States, Missouri | |
| 1275.9.01023 Boehringer Ingelheim Investigational Site | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| 1275.9.01002 Boehringer Ingelheim Investigational Site | |
| Omaha, Nebraska, United States | |
| United States, New Hampshire | |
| 1275.9.01007 Boehringer Ingelheim Investigational Site | |
| Newington, New Hampshire, United States | |
| United States, North Carolina | |
| 1275.9.01016 Boehringer Ingelheim Investigational Site | |
| Asheboro, North Carolina, United States | |
| 1275.9.01025 Boehringer Ingelheim Investigational Site | |
| Burlington, North Carolina, United States | |
| 1275.9.01014 Boehringer Ingelheim Investigational Site | |
| Shelby, North Carolina, United States | |
| 1275.9.01028 Boehringer Ingelheim Investigational Site | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| 1275.9.01018 Boehringer Ingelheim Investigational Site | |
| Dayton, Ohio, United States | |
| United States, Oregon | |
| 1275.9.01005 Boehringer Ingelheim Investigational Site | |
| Corvallis, Oregon, United States | |
| United States, Texas | |
| 1275.9.01032 Boehringer Ingelheim Investigational Site | |
| Corpus Christi, Texas, United States | |
| 1275.9.01030 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| 1275.9.01021 Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| Australia, New South Wales | |
| 1275.9.61009 Boehringer Ingelheim Investigational Site | |
| Liverpool, New South Wales, Australia | |
| 1275.9.61001 Boehringer Ingelheim Investigational Site | |
| St Leonards, New South Wales, Australia | |
| Australia, Queensland | |
| 1275.9.61003 Boehringer Ingelheim Investigational Site | |
| Carina Heights, Queensland, Australia | |
| 1275.9.61002 Boehringer Ingelheim Investigational Site | |
| Herston, Queensland, Australia | |
| Australia, Victoria | |
| 1275.9.61006 Boehringer Ingelheim Investigational Site | |
| Malvern, Victoria, Australia | |
| Australia, Western Australia | |
| 1275.9.61007 Boehringer Ingelheim Investigational Site | |
| Nedlands, Western Australia, Australia | |
| Brazil | |
| 1275.9.55002 Boehringer Ingelheim Investigational Site | |
| Brasilia, Brazil | |
| 1275.9.55005 Boehringer Ingelheim Investigational Site | |
| Goiania, Brazil | |
| 1275.9.55001 Boehringer Ingelheim Investigational Site | |
| Sao Paulo, Brazil | |
| 1275.9.55003 Boehringer Ingelheim Investigational Site | |
| Sao Paulo, Brazil | |
| 1275.9.55004 Boehringer Ingelheim Investigational Site | |
| Sao Paulo, Brazil | |
| Canada, British Columbia | |
| 1275.9.01101 Boehringer Ingelheim Investigational Site | |
| Burnaby, British Columbia, Canada | |
| 1275.9.01103 Boehringer Ingelheim Investigational Site | |
| Victoria, British Columbia, Canada | |
| Canada, Ontario | |
| 1275.9.01105 Boehringer Ingelheim Investigational Site | |
| Cornwall, Ontario, Canada | |
| 1275.9.01106 Boehringer Ingelheim Investigational Site | |
| Hamilton, Ontario, Canada | |
| 1275.9.01104 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| 1275.9.01102 Boehringer Ingelheim Investigational Site | |
| Waterloo, Ontario, Canada | |
| El Salvador | |
| 1275.9.34008 Boehringer Ingelheim Investigational Site | |
| Barcelona, El Salvador | |
| France | |
| 1275.9.33006 Boehringer Ingelheim Investigational Site | |
| Bourg des Comptes, France | |
| 1275.9.33008 Boehringer Ingelheim Investigational Site | |
| Dessenheim, France | |
| 1275.9.33003 Boehringer Ingelheim Investigational Site | |
| La Riche, France | |
| 1275.9.33012 Boehringer Ingelheim Investigational Site | |
| Paris, France | |
| 1275.9.33002 Boehringer Ingelheim Investigational Site | |
| Saint Avertin, France | |
| 1275.9.33005 Boehringer Ingelheim Investigational Site | |
| Savonnieres, France | |
| 1275.9.33004 Boehringer Ingelheim Investigational Site | |
| Tours, France | |
| Korea, Republic of | |
| 1275.9.82006 Boehringer Ingelheim Investigational Site | |
| Daejeon, Korea, Republic of | |
| 1275.9.82009 Boehringer Ingelheim Investigational Site | |
| Deagu, Korea, Republic of | |
| 1275.9.82002 Boehringer Ingelheim Investigational Site | |
| Goyang, Korea, Republic of | |
| 1275.9.82004 Boehringer Ingelheim Investigational Site | |
| Seongnam, Korea, Republic of | |
| 1275.9.82001 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1275.9.82005 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1275.9.82007 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1275.9.82008 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1275.9.82010 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| New Zealand | |
| 1275.9.64005 Boehringer Ingelheim Investigational Site | |
| Auckland, New Zealand, New Zealand | |
| 1275.9.64006 Boehringer Ingelheim Investigational Site | |
| Auckland, New Zealand, New Zealand | |
| 1275.9.64008 Boehringer Ingelheim Investigational Site | |
| Birkenhead Auckland, New Zealand | |
| 1275.9.64007 Boehringer Ingelheim Investigational Site | |
| Christchurch Central, New Zealand | |
| 1275.9.64004 Boehringer Ingelheim Investigational Site | |
| Christchurch, New Zealand, New Zealand | |
| 1275.9.64002 Boehringer Ingelheim Investigational Site | |
| Otahuhu Auckland, New Zealand | |
| 1275.9.64001 Boehringer Ingelheim Investigational Site | |
| Takapuna Auckland, New Zealand | |
| 1275.9.64003 Boehringer Ingelheim Investigational Site | |
| Tauranga, New Zealand, New Zealand | |
| Norway | |
| 1275.9.47001 Boehringer Ingelheim Investigational Site | |
| Bergen, Norway | |
| 1275.9.47002 Boehringer Ingelheim Investigational Site | |
| Oslo, Norway | |
| 1275.9.47003 Boehringer Ingelheim Investigational Site | |
| Oslo, Norway | |
| 1275.9.47007 Boehringer Ingelheim Investigational Site | |
| Oslo, Norway | |
| 1275.9.47006 Boehringer Ingelheim Investigational Site | |
| Svelvik, Norway | |
| Spain | |
| 1275.9.34011 Boehringer Ingelheim Investigational Site | |
| A Coruña, Spain | |
| 1275.9.34009 Boehringer Ingelheim Investigational Site | |
| Alicante, Spain | |
| 1275.9.34005 Boehringer Ingelheim Investigational Site | |
| Badía del Vallès - Barcelona, Spain | |
| 1275.9.34001 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1275.9.34003 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1275.9.34004 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1275.9.34002 Boehringer Ingelheim Investigational Site | |
| Sevilla, Spain | |
| 1275.9.34010 Boehringer Ingelheim Investigational Site | |
| Valencia, Spain | |
| 1275.9.34006 Boehringer Ingelheim Investigational Site | |
| Vic, Spain | |
| Taiwan | |
| 1275.9.88606 Boehringer Ingelheim Investigational Site | |
| Kaohsiung, Taiwan | |
| 1275.9.88607 Boehringer Ingelheim Investigational Site | |
| Kaohsiung, Taiwan | |
| 1275.9.88602 Boehringer Ingelheim Investigational Site | |
| New Taipei, Taiwan | |
| 1275.9.88603 Boehringer Ingelheim Investigational Site | |
| Taichung, Taiwan | |
| 1275.9.88604 Boehringer Ingelheim Investigational Site | |
| Taichung, Taiwan | |
| 1275.9.88605 Boehringer Ingelheim Investigational Site | |
| Tainan, Taiwan | |
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01734785 History of Changes |
| Other Study ID Numbers: |
1275.9 2012-002270-31 ( EudraCT Number: EudraCT ) |
| First Posted: | November 28, 2012 Key Record Dates |
| Results First Posted: | April 18, 2016 |
| Last Update Posted: | July 11, 2016 |
| Last Verified: | June 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Empagliflozin Linagliptin Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |