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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:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01897532
First received: July 9, 2013
Last updated: November 21, 2016
Last verified: November 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 occurence of any of the following adjudicated components of the primary composite endpoint: cardiovascular death, non fatal myocardial infarction, non fatal stroke and hospitalization for unstable angina pectoris [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first occurence of any of the following adjudicated components: cardiovascular death, non fatal myocardial infarction and non fatal stroke [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Time to first occurence of any of the following adjudicated composite renal endpoint: renal death, end stage renal disease and a sustained decrease of 50% or more in estimated glomerular filtration rate [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 8300
Study Start Date: July 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linagliptin Drug: Linagliptin
Placebo Comparator: Placebo Drug: Placebo
placebo matching tablets

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 (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
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: NCT01897532

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Milwaukee, Wisconsin, United States
Argentina
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Bahía Blanca, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Brazil
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Canada
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Chile
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Debrecen, Hungary
Boehringer Ingelheim Investigational Site
Eger, Hungary
Boehringer Ingelheim Investigational Site
Hodmezovasarhely, Hungary
Boehringer Ingelheim Investigational Site
Kaposvar, Hungary
Boehringer Ingelheim Investigational Site
Komarom, Hungary
Boehringer Ingelheim Investigational Site
Letavertes, Hungary
Boehringer Ingelheim Investigational Site
Miskolc, Hungary
Boehringer Ingelheim Investigational Site
Pecs, Hungary
Boehringer Ingelheim Investigational Site
Szeged, Hungary
Boehringer Ingelheim Investigational Site
Zalaegerszeg, Hungary
Israel
Boehringer Ingelheim Investigational Site
Afula, Israel
Boehringer Ingelheim Investigational Site
Haifa, Israel
Boehringer Ingelheim Investigational Site
Herzliya, Israel
Boehringer Ingelheim Investigational Site
Holon, Israel
Boehringer Ingelheim Investigational Site
Jerusalem, Israel
Boehringer Ingelheim Investigational Site
Kfar-Saba, Israel
Boehringer Ingelheim Investigational Site
Nahariya, Israel
Boehringer Ingelheim Investigational Site
Safed, Israel
Boehringer Ingelheim Investigational Site
Tel Aviv, Israel
Japan
Boehringer Ingelheim Investigational Site
Iizuka-shi, Japan
Boehringer Ingelheim Investigational Site
Kawanishi-shi, Japan
Boehringer Ingelheim Investigational Site
Kawasaki-shi, Japan
Boehringer Ingelheim Investigational Site
Kitakyushu-shi, Japan
Boehringer Ingelheim Investigational Site
Matsudo-shi, Japan
Boehringer Ingelheim Investigational Site
Matsuyama-shi, Japan
Boehringer Ingelheim Investigational Site
Nagano-shi, Japan
Boehringer Ingelheim Investigational Site
Nagoya-shi, Japan
Boehringer Ingelheim Investigational Site
Sashima-gun, Japan
Boehringer Ingelheim Investigational Site
Takamatsu-shi, Japan
Korea, Republic of
Boehringer Ingelheim Investigational Site
Anyang-si, Korea, Republic of
Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site
Goyang-si, Korea, Republic of
Boehringer Ingelheim Investigational Site
Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site
Wonju, Korea, Republic of
Malaysia
Boehringer Ingelheim Investigational Site
Alor Setar, Malaysia
Boehringer Ingelheim Investigational Site
Klang, Malaysia
Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
Boehringer Ingelheim Investigational Site
Kuantan, Malaysia
Boehringer Ingelheim Investigational Site
Petaling Jaya, Malaysia
Boehringer Ingelheim Investigational Site
Pulau Pinang, Malaysia
Boehringer Ingelheim Investigational Site
Serdang, Malaysia
Boehringer Ingelheim Investigational Site
Seri Manjung, Malaysia
Boehringer Ingelheim Investigational Site
Taiping, Malaysia
Boehringer Ingelheim Investigational Site
Tampin, Malaysia
Mexico
Boehringer Ingelheim Investigational Site
Chihuahua, Mexico
Boehringer Ingelheim Investigational Site
Cuautitlan Izcalli, Mexico
Boehringer Ingelheim Investigational Site
Culiacan, Mexico
Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site
Merida, Mexico
Boehringer Ingelheim Investigational Site
Mexico, Mexico
Boehringer Ingelheim Investigational Site
Monterrey, Mexico
Boehringer Ingelheim Investigational Site
Morelia, Mexico
Boehringer Ingelheim Investigational Site
Queretaro, Mexico
Boehringer Ingelheim Investigational Site
Tijuana, Mexico
Boehringer Ingelheim Investigational Site
Zapopan, Mexico
Netherlands
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Arnhem, Netherlands
Boehringer Ingelheim Investigational Site
Dordrecht, Netherlands
Boehringer Ingelheim Investigational Site
Groningen, Netherlands
Boehringer Ingelheim Investigational Site
Hoogeveen, Netherlands
Boehringer Ingelheim Investigational Site
Kemerovo, Netherlands
Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
Boehringer Ingelheim Investigational Site
Utrecht, Netherlands
Boehringer Ingelheim Investigational Site
Waalwijk, Netherlands
Boehringer Ingelheim Investigational Site
Zutphen, Netherlands
Poland
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Chorzow, Poland
Boehringer Ingelheim Investigational Site
Gdansk, Poland
Boehringer Ingelheim Investigational Site
Gdynia, Poland
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Grodzisk Mazowiecki, Poland
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Katowice, Poland
Boehringer Ingelheim Investigational Site
Kielce, Poland
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Krakow, Poland
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Lodz, Poland
Boehringer Ingelheim Investigational Site
Lublin, Poland
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Nowy Duninow, Poland
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Oswiecim, Poland
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Parczew, Poland
Boehringer Ingelheim Investigational Site
Poznan, Poland
Boehringer Ingelheim Investigational Site
Pulawy, Poland
Boehringer Ingelheim Investigational Site
Ruda Slaska, Poland
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Rzeszow, Poland
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Sochaczew, Poland
Boehringer Ingelheim Investigational Site
Sroda Wielkopolska, Poland
Boehringer Ingelheim Investigational Site
Staszow, Poland
Boehringer Ingelheim Investigational Site
Torun, Poland
Boehringer Ingelheim Investigational Site
Warsaw, Poland
Boehringer Ingelheim Investigational Site
Warszaw, Poland
Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Boehringer Ingelheim Investigational Site
Zamosc, Poland
Boehringer Ingelheim Investigational Site
Zgierz, Poland
Portugal
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Braga, Portugal
Boehringer Ingelheim Investigational Site
Coimbra, Portugal
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Lisboa, Portugal
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Porto, Portugal
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V. N. Gaia, Portugal
Romania
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Alba Iulia, Romania
Boehringer Ingelheim Investigational Site
Bucuresti, Romania
Boehringer Ingelheim Investigational Site
Buzau, Romania
Boehringer Ingelheim Investigational Site
Galati, Romania
Boehringer Ingelheim Investigational Site
Iasi, Romania
Boehringer Ingelheim Investigational Site
Oradea, Romania
Boehringer Ingelheim Investigational Site
Ploiesti, Romania
Boehringer Ingelheim Investigational Site
Sibiu, Romania
Boehringer Ingelheim Investigational Site
Targu Mures, Romania
Boehringer Ingelheim Investigational Site
Timisoara, Romania
Russian Federation
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Barnaul, Russian Federation
Boehringer Ingelheim Investigational Site
Kemerovo, Russian Federation
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
Boehringer Ingelheim Investigational Site
Novosibirsk, Russian Federation
Boehringer Ingelheim Investigational Site
Omsk, Russian Federation
Boehringer Ingelheim Investigational Site
Perm, Russian Federation
Boehringer Ingelheim Investigational Site
Ryazan, Russian Federation
Boehringer Ingelheim Investigational Site
Saint-Petersburg, Russian Federation
Boehringer Ingelheim Investigational Site
Sestroretsk, Russian Federation
Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Boehringer Ingelheim Investigational Site
Tomsk, Russian Federation
South Africa
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Alberton, South Africa
Boehringer Ingelheim Investigational Site
Bloemfontein, South Africa
Boehringer Ingelheim Investigational Site
Cape Town, South Africa
Boehringer Ingelheim Investigational Site
Durban, South Africa
Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
Boehringer Ingelheim Investigational Site
Pretoria, South Africa
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Verulam, South Africa
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Worcester, South Africa
Spain
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Almeria, Spain
Boehringer Ingelheim Investigational Site
Alzira, Spain
Boehringer Ingelheim Investigational Site
Badalona, Spain
Boehringer Ingelheim Investigational Site
Barcelona, Spain
Boehringer Ingelheim Investigational Site
Centelles, Spain
Boehringer Ingelheim Investigational Site
Madrid, Spain
Boehringer Ingelheim Investigational Site
Malaga, Spain
Boehringer Ingelheim Investigational Site
Segovia, Spain
Boehringer Ingelheim Investigational Site
Sevilla, Spain
Boehringer Ingelheim Investigational Site
Valencia, Spain
Boehringer Ingelheim Investigational Site
Villamartin, Spain
Taiwan
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Kaohsiung, Taiwan
Boehringer Ingelheim Investigational Site
New Taipei City, Taiwan
Boehringer Ingelheim Investigational Site
Taichung, Taiwan
Boehringer Ingelheim Investigational Site
Tainan, Taiwan
Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Boehringer Ingelheim Investigational Site
Taoyuan County, Taiwan
Ukraine
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Chernivtsi, Ukraine
Boehringer Ingelheim Investigational Site
Dnipropetrovsk, Ukraine
Boehringer Ingelheim Investigational Site
Ivano-Frankivsk, Ukraine
Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
Boehringer Ingelheim Investigational Site
Kyiv, Ukraine
Boehringer Ingelheim Investigational Site
Lviv, Ukraine
Boehringer Ingelheim Investigational Site
Poltava, Ukraine
Boehringer Ingelheim Investigational Site
Sumy, Ukraine
Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
United Kingdom
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Airdrie, United Kingdom
Boehringer Ingelheim Investigational Site
Birmingham, United Kingdom
Boehringer Ingelheim Investigational Site
Bradford on Avon, United Kingdom
Boehringer Ingelheim Investigational Site
Chesterfield, United Kingdom
Boehringer Ingelheim Investigational Site
Dumfries, United Kingdom
Boehringer Ingelheim Investigational Site
Dundee, United Kingdom
Boehringer Ingelheim Investigational Site
Exeter, United Kingdom
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
Boehringer Ingelheim Investigational Site
Leicester, United Kingdom
Boehringer Ingelheim Investigational Site
London, United Kingdom
Boehringer Ingelheim Investigational Site
Swansea, United Kingdom
Boehringer Ingelheim Investigational Site
Welwyn Garden City, United Kingdom
Boehringer Ingelheim Investigational Site
Wolverhampton, 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 
Study First Received: July 9, 2013
Last Updated: November 21, 2016
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: China Food and Drug Administration (CFDA)
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
India: Central Drug Standard Control Organization
Israel: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Malaysia: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
Philippines: Bureau of Food and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russian Federation: Ministry of Health and Social Development Russian Federation
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on December 08, 2016