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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 10, 2013
End Date:January 18, 2018

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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

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 Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a
background of standard of care.


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 Glucagon-like Peptide 1 (GLP-1)
receptor agonists, Dipeptidyl-peptidase 4 (DPP-4) inhibitors or Sodium Glucose Linked
Transporter 2 (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 cardiovascular (CV) events defined by: 1) albuminuria (micro or macro)
and previous macrovascular disease and/or 2) impaired renal function with predefined
Urine Albumin Creatinine Ratio (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
Alanine Transaminase (ALT) (SGPT), Aspartate transaminase (AST) (SGOT), or alkaline
phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1.

4. Estimated Glomerular filtration Rate (eGFR) <15 ml/min/1.73 m2 (severe renal
impairment or End Stage Renal Disease (ESRD), Modification of Diet in Renal Disease
(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-melanoma skin 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 Transient Ischemic Attack (TIA) <= 3 months prior to visit 1 (screening).
We found this trial at
198
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7309 West Flagler Street
North Miami Beach, Florida 33144
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201 Dowman Dr
Atlanta, Georgia 30303
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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304 Northeast 1st Street
Chiefland, Florida 32626
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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820 Avenida Espora
Adrogue,
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Akron, Ohio 44304
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Alpena, Michigan 49707
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1616 East Pleasant Valley Boulevard
Altoona, Pennsylvania 16602
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Altoona, Pennsylvania 16602
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Arvada, Colorado 80002
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Atlanta, Georgia 30308
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Bainbridge, Georgia 39819
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Baltimore, Maryland 21229
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Baltimore, Maryland 21236
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1217 Grand Avenue
Bedford, Texas 76022
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301 West Lincoln Street
Belleville, Illinois 62220
1734
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3955 Bonita Road
Bonita, California 91902
1071
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2609 Woolbright Road
Boynton Beach, Florida 33436
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Boynton Beach, Florida 33472
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Bradenton, Florida 34209
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Brandon, Florida 33511
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Bristol, Tennessee 37620
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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Brooklyn, New York 11206
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Burke, Virginia 22015
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1234 Huffman Mill Road
Burlington, North Carolina 27215
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Calabash, North Carolina 28467
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Carlisle, Ohio 45005
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Carriere, Mississippi 39426
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Charleston, South Carolina 29406
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 00000
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Chicago, Illinois 60607
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Clearwater, Florida 33756
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Clinton, Utah 84015
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Corvallis, Oregon 97330
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Cumming, Georgia 30041
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Dallas, Texas 75093
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Decatur, Georgia 30035
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15300 Jog Road
Delray Beach, Florida 33446
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950 East Harvard Avenue
Denver, Colorado 80210
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Doylestown, Pennsylvania 18901
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Doylestown, Pennsylvania 18901
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Draper, Utah 84020
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2400 Big Timber Road
Elgin, Illinois 60124
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824 Elizabeth Avenue
Elizabeth, New Jersey 07201
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1201 Flushing Road
Flint, Michigan 48504
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Fort Lauderdale, Florida 33312
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3107 Stirling Road
Fort Lauderdale, Florida 33312
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Franklin, Indiana 46131
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Fresno, California 93720
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Gaffney, South Carolina 29341
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Gastonia, North Carolina 28054
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Greenfield, Indiana 46140
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Greensboro, North Carolina 27408
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3500 Duluth Park Lane Northwest
Greenville, South Carolina 29601
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Greer, South Carolina 29651
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Harrisburg, Arkansas 72432
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Hialeah, Florida 33012
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3914 West 12th Avenue
Hialeah, Florida 33012
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Hickory, North Carolina 28602
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Homestead, Florida 33032
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Houston, Texas 77074
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16001 Park Ten Place
Houston, Texas 77079
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Houston, Texas 77079
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12121 Richmond Avenue
Houston, Texas 77082
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1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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Huntsville, Alabama 35801
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6800 North MacArthur Boulevard
Irving, Texas 75039
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Irving, Texas 75061
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Jacksonville, Florida 32277
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Jacksonville, Florida 32216
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Jersey Shore, Pennsylvania 17740
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Johnson City, New York 13790
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301 Med Tech Parkway
Johnson City, Tennessee 37604
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Joliet, Illinois 60435
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Kalispell, Montana 59901
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Kansas City, Missouri 64108
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21304 Provincial Boulevard
Katy, Texas 77450
1874
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4671 South Congress Avenue
Lake Clarke Shores, Florida 33406
2696
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Lakeland, Florida 33805
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Las Vegas, Nevada 89120
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Lexington, Kentucky 40504
2005
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