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Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897532
First Posted: July 12, 2013
Last Update Posted: August 3, 2017
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.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with T2DM and to compare outcomes against placebo, on a background of standard of care.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: Linagliptin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CARMELINA: A Multicenter, International, Randomized, Parallel Group, Double-blind, Placebo-controlled, Cardiovascular Safety and Renal Microvascular Outcome Study With Linagliptin, 5 mg Once Daily in Patients With Type 2 Diabetes Mellitus at High Vascular Risk

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Time to the first occurrence of any of the following by adjudication confirmed components of the primary composite endpoint (3-point MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: 54 months ]

Secondary Outcome Measures:
  • Time to the first occurrence of any of the following by adjudication confirmed components: Composite renal endpoint (renal death, sustained end stage renal disease, sustained decrease of 40% or more in estimated glomerular filtration rate) [ Time Frame: 54 months ]

Enrollment: 7003
Actual Study Start Date: July 10, 2013
Estimated Study Completion Date: December 11, 2017
Estimated Primary Completion Date: December 11, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linagliptin Drug: Linagliptin
Placebo Comparator: Placebo Drug: Placebo
placebo matching tablets

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Documented diagnosis of T2DM before visit 1(screening).
  2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if => consecutive 7 days.
  3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than 10% within the 8 weeks prior to randomization compared with the daily insulin dose at randomization.
  4. HbA1c of => 6.5% and <= 10.0% at Visit 1 (screening)
  5. Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1
  6. Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening)
  7. Signed and dated written informed consent by date of Visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure
  8. High risk of CV events defined by: 1) albuminuria (micro or macro) and previous macrovascular disease and/or 2) impaired renal function with predefined UACR

Exclusion criteria:

  1. Type 1 diabetes mellitus.
  2. Treatment (=> 7 consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials where these antidiabetic drugs have been provided to the patient.
  3. Active liver disease or impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1.
  4. eGFR <15 ml/min/1.73 m2 (severe renal impairment or ESRD, MDRD formula), as determined during screening at Visit 1 and/or the need for maintenance dialysis.
  5. Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic) or intervention (gastric sleeve).
  6. Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent.
  7. Known hypersensitivity or allergy to the investigational products or its excipients.
  8. Any previous or current alcohol or drug abuse that would interfere with trial participation in the opinion of the investigator.
  9. Participation in another trial with an investigational drug ongoing or within 2 months prior to visit 1 (screening).
  10. Pre-menopausal women (last menstruation = 1 year prior to informed consent) who are nursing or pregnant, are of child-bearing potential and are not practicing an acceptable method of birth control (acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local authorities), double barrier method and vasectomised partner) or do not plan to continue using acceptable method of birth control throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
  11. Patients considered unreliable by the investigator concerning the requirements for follow up during the study and/or compliance with study drug administration, have a life expectancy less than 5 years for non-CV causes, or have cancer other than non-melanomaskin cancer within last 3 years, or has any other condition than mentioned which in the opinion of the investigator, would not allow safe participation in the study.
  12. Acute coronary syndrome (ACS), diagnosed <= 2 months prior to visit 1 (screening).
  13. Stroke or TIA <= 3 months prior to visit 1 (screening).
  Contacts and Locations
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): NCT01897532


  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States
Scottsboro, Alabama, United States
Tuscumbia, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Harrisburg, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Bonita, California, United States
Concord, California, United States
Fresno, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
Los Osos, California, United States
North Hollywood, California, United States
Northridge, California, United States
Oceanside, California, United States
San Dimas, California, United States
San Jose, California, United States
United States, Colorado
Arvada, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
United States, Florida
Boynton Beach, Florida, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Delray Beach, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Jacksonville, Florida, United States
Lake Clarke Shores, Florida, United States
Lakeland, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Saint Petersburg, Florida, United States
Sarasota, Florida, United States
West Palm Beach, Florida, United States
Williston, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Bainbridge, Georgia, United States
Cumming, Georgia, United States
Decatur, Georgia, United States
Tucker, Georgia, United States
United States, Illinois
Belleville, Illinois, United States
Chicago, Illinois, United States
Elgin, Illinois, United States
Joliet, Illinois, United States
United States, Indiana
Avon, Indiana, United States
Franklin, Indiana, United States
Greenfield, Indiana, United States
Valparaiso, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
Waterloo, Iowa, United States
United States, Kansas
Topeka, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
United States, Louisiana
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
Salisbury, Maryland, United States
United States, Michigan
Alpena, Michigan, United States
Ann Arbor, Michigan, United States
Flint, Michigan, United States
Petoskey, Michigan, United States
Sterling Heights, Michigan, United States
United States, Minnesota
Saint Paul, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Montana
Kalispell, Montana, United States
United States, Nebraska
North Platte, Nebraska, United States
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Elizabeth, New Jersey, United States
Linden, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Johnson City, New York, United States
Saratoga Springs, New York, United States
The Bronx, New York, United States
United States, North Carolina
Burlington, North Carolina, United States
Calabash, North Carolina, United States
Gastonia, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Mooresville, North Carolina, United States
Morehead City, North Carolina, United States
Salisbury, North Carolina, United States
Wilson, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Carlisle, Ohio, United States
Dayton, Ohio, United States
Norton, Ohio, United States
Springfield, Ohio, United States
Toledo, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Corvallis, Oregon, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Smithfield, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Gaffney, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Rock Hill, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Bristol, Tennessee, United States
United States, Texas
Austin, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Katy, Texas, United States
New Braunfels, Texas, United States
Odessa, Texas, United States
Pearland, Texas, United States
San Antonio, Texas, United States
Sealy, Texas, United States
Tomball, Texas, United States
Victoria, Texas, United States
United States, Utah
Clinton, Utah, United States
Ogden, Utah, United States
United States, Virginia
Burke, Virginia, United States
Herndon, Virginia, United States
Manassas, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Salem, Virginia, United States
United States, Washington
Port Orchard, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Argentina
Bahia Blanca, Argentina
Caba, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma de Bs As, Argentina
Cordoba, Argentina
Corrientes, Argentina
Córdoba, Argentina
Godoy Cruz, Argentina
Haedo, Argentina
La Plata, Argentina
Mar del Plata, Argentina
Mendoza, Argentina
Parana, Argentina
Quilmes, Argentina
Rosario, Argentina
Salta, Argentina
San Miguel de Tucuman, Argentina
San Miguel de Tucumán, Argentina
San Nicolas, Argentina
San Vicente, Argentina
Santa Fe, Argentina
Venado Tuerto, Argentina
Villa Maria, Argentina
Zarate, Argentina
Brazil
Belo Horizonte, Brazil
Belém, Brazil
Campina Grande do Sul, Brazil
Campinas, Brazil
Canoas, Brazil
Curitiba, Brazil
Fortaleza, Brazil
Goiania, Brazil
Marília, Brazil
Passo Fundo, Brazil
Porto Alegre, Brazil
Recife, Brazil
Rio de Janeiro, Brazil
Santa Maria, Brazil
Sao Jose do Rio Preto, Brazil
Sao Paulo, Brazil
São Paulo, Brazil
Tatui, Brazil
Uberlândia, Brazil
Bulgaria
Blagoevgrad, Bulgaria
Byala, Bulgaria
Kazanlak, Bulgaria
Plovdiv, Bulgaria
Ruse, Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Canada, Alberta
Edmonton, Alberta, Canada
Red Deer, Alberta, Canada
Canada, British Columbia
Penticton, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Migration Data
Brossard, Migration Data, Canada
Greenfield Park, Migration Data, Canada
Laval, Migration Data, Canada
Montreal, Migration Data, Canada
Quebec, Migration Data, Canada
Ville Saint-Laurent, Migration Data, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Barrie, Ontario, Canada
Etobicoke, Ontario, Canada
Newmarket, Ontario, Canada
Sudbury, Ontario, Canada
Canada, Quebec
Longueuil, Quebec, Canada
St-Jerome, Quebec, Canada
Canada
Quebec, Canada
Chile
Punta Arenas, Chile
Santiago, Chile
Valdivia, Chile
Viña del Mar, Chile
China
Beijing, China
Guangzhou, China
Guiyang, China
Hangzhou, China
Jinan, China
Nanning, China
Shanghai, China
Xi'an, China
Yinchuan, China
Colombia
Armenia, Colombia
Barranquilla, Colombia
Bogota, Colombia
Bogotá, Colombia
Cali, Colombia
Espinal, Colombia
Medellin, Colombia
Pasto, Colombia
Zipaquirá, Colombia
Croatia
Karlovac, Croatia
Krapinske Toplice, Croatia
Slavonski Brod, Croatia
Varazdin, Croatia
Zagreb, Croatia
Czechia
Brno, Czechia
Bruntal, Czechia
Chocen, Czechia
Dolni Brezany, Czechia
Hodonin, Czechia
Jindrichuv Hradec, Czechia
Liberec, Czechia
Marianske Lazne, Czechia
Nachod, Czechia
Olomouc, Czechia
Praha 10, Czechia
Praha 2, Czechia
Praha 4 - Krc, Czechia
Praha 8, Czechia
Slany, Czechia
Germany
Bad Homburg, Germany
Dresden, Germany
Frankfurt am Main, Germany
Frankfurt, Germany
Hohenmölsen, Germany
Leipzig, Germany
Hungary
Baja, Hungary
Balassagyarmat, Hungary
Balatonfured, Hungary
Budapest, Hungary
Debrecen, Hungary
Eger, Hungary
Hodmezovasarhely, Hungary
Kaposvar, Hungary
Komarom, Hungary
Letavertes, Hungary
Miskolc, Hungary
Pecs, Hungary
Szeged, Hungary
Zalaegerszeg, Hungary
Israel
Afula, Israel
Haifa, Israel
Herzliya, Israel
Holon, Israel
Jerusalem, Israel
Kfar-Saba, Israel
Nahariya, Israel
Safed, Israel
Japan
Iizuka-shi, Japan
Kawanishi-shi, Japan
Kawasaki-shi, Japan
Kitakyushu-shi, Japan
Matsudo-shi, Japan
Matsuyama-shi, Japan
Nagano-shi, Japan
Nagoya-shi, Japan
Sashima-gun, Japan
Takamatsu-shi, Japan
Korea, Republic of
Anyang-si, Korea, Republic of
Busan, Korea, Republic of
Goyang-si, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Wonju, Korea, Republic of
Malaysia
Alor Setar, Malaysia
Klang, Malaysia
Kuala Lumpur, Malaysia
Kuantan, Malaysia
Petaling Jaya, Malaysia
Pulau Pinang, Malaysia
Seri Manjung, Malaysia
Taiping, Malaysia
Tampin, Malaysia
Mexico
Chihuahua, Mexico
Cuautitlan Izcalli, Mexico
Culiacan, Mexico
Merida, Mexico
Mexico, Mexico
Monterrey, Mexico
Morelia, Mexico
Queretaro, Mexico
Tijuana, Mexico
Zapopan, Mexico
Netherlands
Dordrecht, Netherlands
Groningen, Netherlands
Hoogeveen, Netherlands
Maastricht, Netherlands
Rotterdam, Netherlands
Utrecht, Netherlands
Waalwijk, Netherlands
Zutphen, Netherlands
Poland
Chorzow, Poland
Gdansk, Poland
Gdynia, Poland
Grodzisk Mazowiecki, Poland
Katowice, Poland
Kielce, Poland
Krakow, Poland
Lodz, Poland
Lublin, Poland
Nowy Duninow, Poland
Oswiecim, Poland
Parczew, Poland
Poznan, Poland
Pulawy, Poland
Ruda Slaska, Poland
Rzeszow, Poland
Sochaczew, Poland
Sroda Wielkopolska, Poland
Staszow, Poland
Torun, Poland
Warsaw, Poland
Warszaw, Poland
Wroclaw, Poland
Zamosc, Poland
Zgierz, Poland
Portugal
Braga, Portugal
Coimbra, Portugal
Lisboa, Portugal
Porto, Portugal
V. N. Gaia, Portugal
Romania
Alba Iulia, Romania
Bucuresti, Romania
Buzau, Romania
Galati, Romania
Iasi, Romania
Oradea, Romania
Ploiesti, Romania
Sibiu, Romania
Targu Mures, Romania
Timisoara, Romania
Russian Federation
Kemerovo, Russian Federation
Moscow, Russian Federation
Novosibirsk, Russian Federation
Omsk, Russian Federation
Perm, Russian Federation
Ryazan, Russian Federation
Saint-Petersburg, Russian Federation
Sestroretsk, Russian Federation
St. Petersburg, Russian Federation
Tomsk, Russian Federation
South Africa
Alberton, South Africa
Bloemfontein, South Africa
Cape Town, South Africa
Durban, South Africa
Johannesburg, South Africa
Krugersdorp, South Africa
Pretoria, South Africa
Verulam, South Africa
Worcester, South Africa
Spain
Almeria, Spain
Alzira, Spain
Barcelona, Spain
Centelles, Spain
Madrid, Spain
Segovia, Spain
Sevilla, Spain
Valencia, Spain
Villamartin, Spain
Taiwan
Kaohsiung, Taiwan
New Taipei City, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Ukraine
Chernivtsi, Ukraine
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Kyiv, Ukraine
Lviv, Ukraine
Poltava, Ukraine
Sumy, Ukraine
Ternopli, Ukraine
Vinnytsia, Ukraine
United Kingdom
Airdrie, United Kingdom
Birmingham, United Kingdom
Bradford on Avon, United Kingdom
Chesterfield, United Kingdom
Dumfries, United Kingdom
Glasgow, United Kingdom
Swansea, United Kingdom
Welwyn Garden City, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01897532     History of Changes
Other Study ID Numbers: 1218.22
2011-004148-23 ( EudraCT Number: EudraCT )
First Submitted: July 9, 2013
First Posted: July 12, 2013
Last Update Posted: August 3, 2017
Last Verified: August 2017

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