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

Use our guide to learn which trials are right for you!

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
sites
San Antonio, Texas 78229
571
mi
from
San Antonio, TX
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
304 Northeast 1st Street
Chiefland, Florida 32626
1031
mi
from
Chiefland, FL
Click here to add this to my saved trials
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
1170
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
1319
mi
from
Miami, FL
Click here to add this to my saved trials
823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
146
mi
from
Topeka, KS
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
32
mi
from
Wichita, KS
Click here to add this to my saved trials
820 Avenida Espora
Adrogue,
5613
mi
from
Adrogue,
Click here to add this to my saved trials
Akron, Ohio 44304
899
mi
from
Akron, OH
Click here to add this to my saved trials
522
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alpena, Michigan 49707
898
mi
from
Alpena, MI
Click here to add this to my saved trials
1616 East Pleasant Valley Boulevard
Altoona, Pennsylvania 16602
1058
mi
from
Altoona, PA
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
1055
mi
from
Altoona, PA
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
808
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Arvada, Colorado 80002
?
mi
from
Arvada, CO
Click here to add this to my saved trials
Atlanta, Georgia 30308
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
517
mi
from
Austin, TX
Click here to add this to my saved trials
Avon, Indiana
630
mi
from
Avon, IN
Click here to add this to my saved trials
Bainbridge, Georgia 39819
890
mi
from
Bainbridge, GA
Click here to add this to my saved trials
Baltimore, Maryland 21229
1144
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21236
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1217 Grand Avenue
Bedford, Texas 76022
345
mi
from
Bedford, TX
Click here to add this to my saved trials
301 West Lincoln Street
Belleville, Illinois 62220
428
mi
from
Belleville, IL
Click here to add this to my saved trials
3955 Bonita Road
Bonita, California 91902
1138
mi
from
Bonita, CA
Click here to add this to my saved trials
2609 Woolbright Road
Boynton Beach, Florida 33436
1291
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Boynton Beach, Florida 33472
1292
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Bradenton, Florida 34209
1132
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brandon, Florida 33511
1126
mi
from
Brandon, FL
Click here to add this to my saved trials
Bristol, Tennessee 37620
864
mi
from
Bristol, TN
Click here to add this to my saved trials
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...
1295
mi
from
Bronx, NY
Click here to add this to my saved trials
Brooklyn, New York 11206
1287
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooksville, Florida
1093
mi
from
Brooksville, FL
Click here to add this to my saved trials
Burke, Virginia 22015
1114
mi
from
Burke, VA
Click here to add this to my saved trials
1234 Huffman Mill Road
Burlington, North Carolina 27215
1017
mi
from
Burlington, NC
Click here to add this to my saved trials
Calabash, North Carolina 28467
?
mi
from
Calabash, NC
Click here to add this to my saved trials
Carlisle, Ohio 45005
738
mi
from
Carlisle, OH
Click here to add this to my saved trials
Carriere, Mississippi 39426
678
mi
from
Carriere, MS
Click here to add this to my saved trials
Charleston, South Carolina 29406
1054
mi
from
Charleston, SC
Click here to add this to my saved trials
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...
1063
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 00000
958
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60607
609
mi
from
Chicago, IL
Click here to add this to my saved trials
609
mi
from
Chicago, IL
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clinton, Utah 84015
792
mi
from
Clinton, UT
Click here to add this to my saved trials
1316
mi
from
Concord, CA
Click here to add this to my saved trials
Corvallis, Oregon 97330
1398
mi
from
Corvallis, OR
Click here to add this to my saved trials
Cumming, Georgia 30041
802
mi
from
Cumming, GA
Click here to add this to my saved trials
Dallas, Texas 75093
330
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
342
mi
from
Dallas, TX
Click here to add this to my saved trials
746
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30035
805
mi
from
Decatur, GA
Click here to add this to my saved trials
15300 Jog Road
Delray Beach, Florida 33446
1292
mi
from
Delray Beach, FL
Click here to add this to my saved trials
950 East Harvard Avenue
Denver, Colorado 80210
407
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
Doylestown, Pennsylvania 18901
1226
mi
from
Doylestown, PA
Click here to add this to my saved trials
Doylestown, Pennsylvania 18901
1227
mi
from
Doylestown, PA
Click here to add this to my saved trials
Draper, Utah 84020
775
mi
from
Draper, UT
Click here to add this to my saved trials
2400 Big Timber Road
Elgin, Illinois 60124
583
mi
from
Elgin, IL
Click here to add this to my saved trials
824 Elizabeth Avenue
Elizabeth, New Jersey 07201
1276
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
1201 Flushing Road
Flint, Michigan 48504
825
mi
from
Flint, MI
Click here to add this to my saved trials
Fort Lauderdale, Florida 33312
1307
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
3107 Stirling Road
Fort Lauderdale, Florida 33312
1309
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Franklin, Indiana 46131
645
mi
from
Franklin, IN
Click here to add this to my saved trials
Fresno, California 93720
1204
mi
from
Fresno, CA
Click here to add this to my saved trials
Gaffney, South Carolina 29341
916
mi
from
Gaffney, SC
Click here to add this to my saved trials
Gastonia, North Carolina 28054
938
mi
from
Gastonia, NC
Click here to add this to my saved trials
Glendale, Arizona 85306
853
mi
from
Glendale, AZ
Click here to add this to my saved trials
?
mi
from
Golden, CO
Click here to add this to my saved trials
Greenfield, Indiana 46140
663
mi
from
Greenfield, IN
Click here to add this to my saved trials
Greensboro, North Carolina 27408
1001
mi
from
Greensboro, NC
Click here to add this to my saved trials
3500 Duluth Park Lane Northwest
Greenville, South Carolina 29601
806
mi
from
Greenville, SC
Click here to add this to my saved trials
Greer, South Carolina 29651
888
mi
from
Greer, SC
Click here to add this to my saved trials
Harrisburg, Arkansas 72432
421
mi
from
Harrisburg, AR
Click here to add this to my saved trials
?
mi
from
Herndon, VA
Click here to add this to my saved trials
Hialeah, Florida 33012
1312
mi
from
Hialeah, FL
Click here to add this to my saved trials
3914 West 12th Avenue
Hialeah, Florida 33012
1312
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hickory, North Carolina 28602
921
mi
from
Hickory, NC
Click here to add this to my saved trials
Homestead, Florida 33032
1325
mi
from
Homestead, FL
Click here to add this to my saved trials
Houston, Texas 77074
569
mi
from
Houston, TX
Click here to add this to my saved trials
16001 Park Ten Place
Houston, Texas 77079
564
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77079
569
mi
from
Houston, TX
Click here to add this to my saved trials
12121 Richmond Avenue
Houston, Texas 77082
568
mi
from
Houston, TX
Click here to add this to my saved trials
1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
572
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
661
mi
from
Huntsville, AL
Click here to add this to my saved trials
6800 North MacArthur Boulevard
Irving, Texas 75039
338
mi
from
Irving, TX
Click here to add this to my saved trials
Irving, Texas 75061
?
mi
from
Irving, TX
Click here to add this to my saved trials
Jacksonville, Florida 32277
1057
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville, Florida 32216
1055
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jersey Shore, Pennsylvania 17740
1119
mi
from
Jersey Shore, PA
Click here to add this to my saved trials
Johnson City, New York 13790
1193
mi
from
Johnson City, NY
Click here to add this to my saved trials
301 Med Tech Parkway
Johnson City, Tennessee 37604
854
mi
from
Johnson City, TN
Click here to add this to my saved trials
Joliet, Illinois 60435
579
mi
from
Joliet, IL
Click here to add this to my saved trials
Kalispell, Montana 59901
1098
mi
from
Kalispell, MT
Click here to add this to my saved trials
Kansas City, Missouri 64108
198
mi
from
Kansas City, MO
Click here to add this to my saved trials
199
mi
from
Kansas City, MO
Click here to add this to my saved trials
21304 Provincial Boulevard
Katy, Texas 77450
563
mi
from
Katy, TX
Click here to add this to my saved trials
4671 South Congress Avenue
Lake Clarke Shores, Florida 33406
1287
mi
from
Lake Clarke Shores, FL
Click here to add this to my saved trials
Lakeland, Florida 33805
1135
mi
from
Lakeland, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89120
959
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lexington, Kentucky 40504
725
mi
from
Lexington, KY
Click here to add this to my saved trials