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CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01243424
First received: November 17, 2010
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: linagliptin
Drug: glimepiride
Drug: linagliptin placebo
Drug: glimepride placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Official Title: A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Time to first occurence of any of the following adjudicated components of the primary composite endpoint: CV death, non-fatal MI (excluding silent MI), non-fatal stroke and hospitalisation for unstable angina pectoris [ Time Frame: 400 weeks ]

Secondary Outcome Measures:
  • Time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI) [ Time Frame: 400 weeks ]
  • Proportion of patients on study treatment at study end, that at Final Visit maintain glycemic control (HbA1c <= 7.0%) without need for rescue medication, without any moderate/severe hypoglycaemic episodes and without > 2% weight gain (from V6 on) [ Time Frame: 400 weeks ]
  • Occurence of any of the adjudicated components of the composite primary and composite first key secondary endpoint. [ Time Frame: 400 weeks ]
  • Transitions in albuminuria classes between baseline and Final visit. [ Time Frame: 400 weeks ]
  • Proportion of patients on study treatment at study end, that at Final Visit maintain glycaemic control (HbA1c <= 7.0%) without need for rescue medication and without > 2% weight gain (from V6 on) [ Time Frame: 400 weeks ]
  • Occurence of and time to composite endpoint of all CEC confirmed adjudicated events [ Time Frame: 400 weeks ]
  • Change from baseline to Final Visit in diabetes related laboratory parameters: HbA1c, fasting plasma glucose, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides, Creatinine, eGFR (MDRD formula), Albumin [ Time Frame: 400 weeks ]

Enrollment: 6072
Study Start Date: October 2010
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linagliptin
patient to receive linagliptin or glimepiride placebo overencapsulated tablet QD
Drug: linagliptin
linagliptin tablets 5mg QD
Drug: glimepride placebo
glimepiride placebo
Active Comparator: glimepiride 1-4 mg QD
patient to receive glimepiride 1-4 mg or linagliptin placebo tablet QD
Drug: glimepiride
glimepiride over-encapsulated tablet 1-4 mg QD
Drug: linagliptin placebo
linagliptin placebo

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Type 2 diabetes
  2. Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
  3. Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
  4. BMI =< 45kg/m²
  5. age between >= 40 and =< 85 years
  6. signed and dated written ICF
  7. stable anti-diabetic background for at least 8 wks before study start

Exclusion criteria:

  1. Type 1 diabetes
  2. Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
  3. treatment with any anti-obesity drug less than 3 months before ICF
  4. uncontrolled hyperglycemia
  5. previous or planned bariatric surgery or intervention
  6. current or planned system corticoid treatment
  7. change in thyroid hormones treatment
  8. acute liver disease or impaired hepatic function
  9. pre-planned coronary artery revascularization within 6 months of ICF
  10. known hypersensitivity to any of the components
  11. Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
  12. congestive heart failure class III or IV
  13. acute or chronic metabolic acidosis
  14. hereditary galactose intolerance
  15. alcohol or drug abuse
  16. participation in another trail with IMP given 2 months before IMP start
  17. pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
  18. patients considered reliable by the investigator
  19. acute coronary syndrome =< 6 wks before ICF
  20. stroke or TIA =< 3 months prior to ICF
  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: NCT01243424

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Boehringer Ingelheim Investigational Site
Gyula, Hungary
Boehringer Ingelheim Investigational Site
Hódmezövásárhely, Hungary
Boehringer Ingelheim Investigational Site
Mako, Hungary
Boehringer Ingelheim Investigational Site
Mosonmagyarovar, Hungary
Boehringer Ingelheim Investigational Site
Papa, Hungary
Boehringer Ingelheim Investigational Site
Szekszard, Hungary
India
Boehringer Ingelheim Investigational Site
Ahmedabad, India
Boehringer Ingelheim Investigational Site
Aurangabad, India
Boehringer Ingelheim Investigational Site
Bangalore, Karnataka, India
Boehringer Ingelheim Investigational Site
Bangalore, India
Boehringer Ingelheim Investigational Site
Belgaum, India
Boehringer Ingelheim Investigational Site
Chennai, India
Boehringer Ingelheim Investigational Site
Coimbatore, India
Boehringer Ingelheim Investigational Site
Indore, India
Boehringer Ingelheim Investigational Site
Jaipur, India
Boehringer Ingelheim Investigational Site
Maharashtra, India
Boehringer Ingelheim Investigational Site
Mumbai, Maharastra, India
Boehringer Ingelheim Investigational Site
Mumbai, India
Boehringer Ingelheim Investigational Site
Nagpur, India
Boehringer Ingelheim Investigational Site
Pune, India
Boehringer Ingelheim Investigational Site
Thiruvananthapuram, India
Boehringer Ingelheim Investigational Site
Vijayawada, India
Ireland
Boehringer Ingelheim Investigational Site
Co. Cork, Ireland
Boehringer Ingelheim Investigational Site
Dublin, Ireland
Boehringer Ingelheim Investigational Site
Gorey, Ireland
Boehringer Ingelheim Investigational Site
Wexford, Ireland
Israel
Boehringer Ingelheim Investigational Site
Ashkelon, Israel
Boehringer Ingelheim Investigational Site
Haifa, Israel
Boehringer Ingelheim Investigational Site
Holon, Israel
Boehringer Ingelheim Investigational Site
Jerusalem, Israel
Boehringer Ingelheim Investigational Site
Nahariya, Israel
Boehringer Ingelheim Investigational Site
Tel Hashomer, Israel
Boehringer Ingelheim Investigational Site
Tel-Aviv, Israel
Italy
Boehringer Ingelheim Investigational Site
Cagliari, Italy
Boehringer Ingelheim Investigational Site
Catanzaro, Italy
Boehringer Ingelheim Investigational Site
Genova, Italy
Boehringer Ingelheim Investigational Site
Guastalla (RE), Italy
Boehringer Ingelheim Investigational Site
Messina, Italy
Boehringer Ingelheim Investigational Site
Milano, Italy
Boehringer Ingelheim Investigational Site
Roma, Italy
Boehringer Ingelheim Investigational Site
Sesto San Giovanni (MI), Italy
Japan
Boehringer Ingelheim Investigational Site
Aichi, Nagoya, Japan
Boehringer Ingelheim Investigational Site
Chiba, Matsudo, Japan
Boehringer Ingelheim Investigational Site
Fukushima, Date, Japan
Boehringer Ingelheim Investigational Site
Fukushima, Nihonmatsu, Japan
Boehringer Ingelheim Investigational Site
Fukushima, Sukagawa, Japan
Boehringer Ingelheim Investigational Site
Hyogo, Amagasaki, Japan
Boehringer Ingelheim Investigational Site
Hyogo, Takasago, Japan
Boehringer Ingelheim Investigational Site
Kanagawa, Yokohama, Japan
Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Kumamoto, Yatsushiro, Japan
Boehringer Ingelheim Investigational Site
Miyazaki, Miyazaki, Japan
Boehringer Ingelheim Investigational Site
Saitama, Hanyu, Japan
Boehringer Ingelheim Investigational Site
Tokyo, Itabashi-ku, Japan
Korea, Republic of
Boehringer Ingelheim Investigational Site
Ansan, Korea, Republic of
Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site
Goyang, Korea, Republic of
Boehringer Ingelheim Investigational Site
Jeonju, Korea, Republic of
Boehringer Ingelheim Investigational Site
Pusan, Korea, Republic of
Boehringer Ingelheim Investigational Site
Seongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
Boehringer Ingelheim Investigational Site
Wonju, Korea, Republic of
Boehringer Ingelheim Investigational Site
Yangsan, Korea, Republic of
Malaysia
Boehringer Ingelheim Investigational Site
Johor Bahru, Johor, Malaysia
Boehringer Ingelheim Investigational Site
Kota Bharu, Malaysia
Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
Boehringer Ingelheim Investigational Site
Kuantan, Malaysia
Boehringer Ingelheim Investigational Site
Melaka, Malaysia
Boehringer Ingelheim Investigational Site
Penang, Malaysia
Boehringer Ingelheim Investigational Site
Taiping, Malaysia
Mexico
Boehringer Ingelheim Investigational Site
Acapulco, Mexico
Boehringer Ingelheim Investigational Site
Aguascalientes, Mexico
Boehringer Ingelheim Investigational Site
Distrito Federal, Mexico
Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site
Monterrey, Mexico
Netherlands
Boehringer Ingelheim Investigational Site
's-hertogenbosch, Netherlands
Boehringer Ingelheim Investigational Site
Almere, Netherlands
Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
Boehringer Ingelheim Investigational Site
Beverwijk, Netherlands
Boehringer Ingelheim Investigational Site
Breda, Netherlands
Boehringer Ingelheim Investigational Site
Den Helder, Netherlands
Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
Boehringer Ingelheim Investigational Site
Groningen, Netherlands
Boehringer Ingelheim Investigational Site
Hoorn, Netherlands
Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
Boehringer Ingelheim Investigational Site
Sneek, Netherlands
Boehringer Ingelheim Investigational Site
Velp, Netherlands
Boehringer Ingelheim Investigational Site
Zoetermeer, Netherlands
New Zealand
Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
Boehringer Ingelheim Investigational Site
Dunedin, New Zealand
Boehringer Ingelheim Investigational Site
Newtown Wellington NZ, New Zealand
Boehringer Ingelheim Investigational Site
Tauranga, New Zealand
Norway
Boehringer Ingelheim Investigational Site
Bodø, Norway
Boehringer Ingelheim Investigational Site
Drammen, Norway
Boehringer Ingelheim Investigational Site
Elverum, Norway
Boehringer Ingelheim Investigational Site
Hamar, Norway
Boehringer Ingelheim Investigational Site
Jessheim, Norway
Boehringer Ingelheim Investigational Site
Lierskogen, Norway
Boehringer Ingelheim Investigational Site
Oslo, Norway
Boehringer Ingelheim Investigational Site
Sandvika, Norway
Boehringer Ingelheim Investigational Site
Sarpsborg, Norway
Boehringer Ingelheim Investigational Site
Stavanger, Norway
Boehringer Ingelheim Investigational Site
Ålesund, Norway
Peru
Boehringer Ingelheim Investigational Site
Arequipa, Peru
Boehringer Ingelheim Investigational Site
Huacho, Peru
Boehringer Ingelheim Investigational Site
Lima, Peru
Boehringer Ingelheim Investigational Site
Piura, Peru
Boehringer Ingelheim Investigational Site
San Miguel, Peru
Philippines
Boehringer Ingelheim Investigational Site
Iloilo, Philippines
Boehringer Ingelheim Investigational Site
Lipa City, Batangas, Philippines
Boehringer Ingelheim Investigational Site
Manila, Philippines
Boehringer Ingelheim Investigational Site
Muntinlupa, Philippines
Boehringer Ingelheim Investigational Site
Quezon City, Philippines
Boehringer Ingelheim Investigational Site
San Juan, Philippines
Boehringer Ingelheim Investigational Site
Surigao, Philippines
Portugal
Boehringer Ingelheim Investigational Site
Amadora, Portugal
Boehringer Ingelheim Investigational Site
Carnaxide, Portugal
Boehringer Ingelheim Investigational Site
Coimbra, Portugal
Boehringer Ingelheim Investigational Site
Covilhã, Portugal
Boehringer Ingelheim Investigational Site
Figueira da Foz, Portugal
Boehringer Ingelheim Investigational Site
Lisboa, Portugal
Boehringer Ingelheim Investigational Site
Porto, Portugal
Boehringer Ingelheim Investigational Site
Santa Maria da Feira, Portugal
Romania
Boehringer Ingelheim Investigational Site
Brasov, Romania
Boehringer Ingelheim Investigational Site
Bucharest, Romania
Boehringer Ingelheim Investigational Site
Iasi, Romania
Boehringer Ingelheim Investigational Site
Sibiu, Romania
Boehringer Ingelheim Investigational Site
Tirgoviste, Romania
Russian Federation
Boehringer Ingelheim Investigational Site
Dzerzhinsky, Russian Federation
Boehringer Ingelheim Investigational Site
Izhevsk, Russian Federation
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
Boehringer Ingelheim Investigational Site
Samara, Russian Federation
Boehringer Ingelheim Investigational Site
Saratov, Russian Federation
Serbia
Boehringer Ingelheim Investigational Site
Belgrade, Serbia
Boehringer Ingelheim Investigational Site
Nis, Serbia
Boehringer Ingelheim Investigational Site
Pancevo, Serbia
Boehringer Ingelheim Investigational Site
Subotica, Serbia
Boehringer Ingelheim Investigational Site
Zemun, Serbia
Slovakia
Boehringer Ingelheim Investigational Site
Banska Bystrica, Slovakia
Boehringer Ingelheim Investigational Site
Dolny Kubin, Slovakia
Boehringer Ingelheim Investigational Site
Levice, Slovakia
Boehringer Ingelheim Investigational Site
Nove Zamky, Slovakia
Boehringer Ingelheim Investigational Site
Povazska Bystrica, Slovakia
Boehringer Ingelheim Investigational Site
Zilina, Slovakia
South Africa
Boehringer Ingelheim Investigational Site
Cape Town, South Africa
Boehringer Ingelheim Investigational Site
Durban, South Africa
Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
Boehringer Ingelheim Investigational Site
Lenasia, South Africa
Boehringer Ingelheim Investigational Site
Port Elizabeth, South Africa
Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Boehringer Ingelheim Investigational Site
Somerset West, South Africa
Spain
Boehringer Ingelheim Investigational Site
Barcelona, Spain
Boehringer Ingelheim Investigational Site
Burjassot, Spain
Boehringer Ingelheim Investigational Site
Gijon, Spain
Boehringer Ingelheim Investigational Site
Girona, Spain
Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat, Spain
Boehringer Ingelheim Investigational Site
La Roca del Vallés (Barcelona), Spain
Boehringer Ingelheim Investigational Site
Madrid, Spain
Boehringer Ingelheim Investigational Site
Oviedo, Spain
Boehringer Ingelheim Investigational Site
Pineda de Mar, Spain
Boehringer Ingelheim Investigational Site
Santa Coloma de Gramanet, Spain
Boehringer Ingelheim Investigational Site
Tàrrega, Spain
Boehringer Ingelheim Investigational Site
Valencia, Spain
Sweden
Boehringer Ingelheim Investigational Site
Göteborg, Sweden
Boehringer Ingelheim Investigational Site
Härnösand, Sweden
Boehringer Ingelheim Investigational Site
Järfälla, Sweden
Boehringer Ingelheim Investigational Site
Malmö, Sweden
Boehringer Ingelheim Investigational Site
Rättvik, Sweden
Boehringer Ingelheim Investigational Site
Skanör, Sweden
Boehringer Ingelheim Investigational Site
Uddevalla, Sweden
Boehringer Ingelheim Investigational Site
Vällingby, Sweden
Switzerland
Boehringer Ingelheim Investigational Site
Basel, Switzerland
Boehringer Ingelheim Investigational Site
Bellinzona, Switzerland
Boehringer Ingelheim Investigational Site
Bern, Switzerland
Boehringer Ingelheim Investigational Site
Lugano, Switzerland
Taiwan
Boehringer Ingelheim Investigational Site
Changhua, Taiwan
Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
Boehringer Ingelheim Investigational Site
New Taipei City, Taiwan
Boehringer Ingelheim Investigational Site
Taichung,, Taiwan
Boehringer Ingelheim Investigational Site
Taichung, Taiwan
Boehringer Ingelheim Investigational Site
Tainan, Taiwan
Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Tunisia
Boehringer Ingelheim Investigational Site
Monastir, Tunisia
Boehringer Ingelheim Investigational Site
Sfax, Tunisia
Boehringer Ingelheim Investigational Site
Sousse, Tunisia
Boehringer Ingelheim Investigational Site
Tunis, Tunisia
Ukraine
Boehringer Ingelheim Investigational Site
Donetsk, Ukraine
Boehringer Ingelheim Investigational Site
Ivano-Frankivsk, Ukraine
Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
Boehringer Ingelheim Investigational Site
Kiev, Ukraine
Boehringer Ingelheim Investigational Site
Kyiv, Ukraine
Boehringer Ingelheim Investigational Site
Lvov, Ukraine
Boehringer Ingelheim Investigational Site
Odesa, Ukraine
Boehringer Ingelheim Investigational Site
Vinnitsa, Ukraine
United Kingdom
Boehringer Ingelheim Investigational Site
Addlestone, United Kingdom
Boehringer Ingelheim Investigational Site
Ash Vale, Aldershot, United Kingdom
Boehringer Ingelheim Investigational Site
Birmingham, United Kingdom
Boehringer Ingelheim Investigational Site
Chippenham, United Kingdom
Boehringer Ingelheim Investigational Site
Durham, United Kingdom
Boehringer Ingelheim Investigational Site
Ely, United Kingdom
Boehringer Ingelheim Investigational Site
Gloucester, United Kingdom
Boehringer Ingelheim Investigational Site
Great Yarmouth, United Kingdom
Boehringer Ingelheim Investigational Site
London, United Kingdom
Boehringer Ingelheim Investigational Site
Swansea, United Kingdom
Boehringer Ingelheim Investigational Site
Truro, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01243424     History of Changes
Other Study ID Numbers: 1218.74
2009-013157-15 ( EudraCT Number: EudraCT )
Study First Received: November 17, 2010
Last Updated: March 3, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
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
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on March 22, 2017