A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
NCT ID: NCT03152552
Last Updated: 2019-08-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
125 participants
INTERVENTIONAL
2017-07-25
2018-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LIK066 2.5mg
Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks.
LIK066
LIK066 was supplied in different doses as tablets taken orally.
LIK066 10mg
Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks.
LIK066
LIK066 was supplied in different doses as tablets taken orally.
LIK066 50mg
Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks.
LIK066
LIK066 was supplied in different doses as tablets taken orally.
Empagliflozin
Participants randomized to this treatment arm received empagliflozin once daily for 36 weeks.
Empagliflozin
Empagliflozin was supplied as capsules taken orally.
Placebo
Participants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo.
Placebo
Placebo was supplied as tablets and capsules taken orally.
Interventions
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LIK066
LIK066 was supplied in different doses as tablets taken orally.
Placebo
Placebo was supplied as tablets and capsules taken orally.
Empagliflozin
Empagliflozin was supplied as capsules taken orally.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes with HbA1c between 6.5% and 10.0%
* Documented symptomatic chronic heart failure (NYHA II-IV)
* Plasma NT-proBNP \> 300pg/ml
* eGFR ≥ 45ml/min/1.73m\^2 (calculated by MDRD)
Exclusion Criteria
* Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* History of ketoacidosis, lactic acidosis, or hyperosmolar coma
* Symptomatic genital infection or UTI within 4 weeks of screening
* Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization
* Unstable angina within 3 months of screening
* Isolated right HF due to pulmonary disease
* Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization
* History of lower limb amputation
* Diabetic foot ulcer at screening
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Bradenton, Florida, United States
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Huntsville, Alabama, United States
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Carmichael, California, United States
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Concord, California, United States
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Long Beach, California, United States
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Northridge, California, United States
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Stockton, California, United States
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Colorado Springs, Colorado, United States
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Clearwater, Florida, United States
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Delray Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Gurnee, Illinois, United States
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Bogalusa, Louisiana, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Tacoma, Washington, United States
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires F.D., Argentina
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Buenos Aires, , Argentina
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Graz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Lennik, Brussels Capital, Belgium
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Aalst, , Belgium
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Bonheiden, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Krapinske Toplice, , Croatia
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Rijeka, , Croatia
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Zagreb, , Croatia
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Brandýs nad Labem, Czech Republic, Czechia
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Svitavy, Czech Republic, Czechia
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Třebíč, Czech Republic, Czechia
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Fryštát, , Czechia
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Kolín, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Přerov, , Czechia
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Hellerup, , Denmark
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Svendborg, , Denmark
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Bad Oeynhausen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Frankfurt, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Stuttgart, , Germany
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Budapest, HUN, Hungary
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Budapest, , Hungary
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Szeged, , Hungary
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Szekszárd, , Hungary
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Wilton, Cork, Ireland
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County Limerick, , Ireland
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Dublin, , Ireland
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Bergamo, BG, Italy
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Milan, MI, Italy
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San Donato Milanese, MI, Italy
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Milan, , Italy
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Rimini, , Italy
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Durango, , Mexico
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Alkmaar, , Netherlands
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Groningen, , Netherlands
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Utrecht, , Netherlands
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Venlo, , Netherlands
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Loerenskog, , Norway
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Oslo, , Norway
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Trondheim, , Norway
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Warsaw, , Poland
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Wroclaw, , Poland
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Ponce, , Puerto Rico
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Singapore, , Singapore
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Bloemfontein, Free State, South Africa
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Paarl, Western Cape, South Africa
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Worcester, , South Africa
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Wŏnju, Gangwon-do, South Korea
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Bundang Gu, Gyeonggi-do, South Korea
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Cheongju-si, North Chungcheong, South Korea
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Seoul, , South Korea
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Seville, Andalusia, Spain
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Villamartín, Cadiz, Spain
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Cáceres, Extremadura, Spain
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Valencia, Valencia, Spain
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Changhua, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Chelmsford, Essex, United Kingdom
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London, GBR, United Kingdom
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Sunderland, Tyne and Wear, United Kingdom
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Birmingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003084-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLIK066B2204
Identifier Type: -
Identifier Source: org_study_id
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