- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01468987
En undersøgelse af deltagere med type 2-diabetes mellitus (IMAGINE 4)
Virkningen af LY2605541 versus insulin Glargine for patienter med type 2-diabetes mellitus Avanceret til multipel injektionsbolus insulin med insulin Lispro: en dobbeltblind, randomiseret, 26-ugers undersøgelse - IMAGINE 4-undersøgelsen
Formålet med denne undersøgelse er:
- For at sammenligne blodsukkerkontrol (blodsukker) på LY2605541 med insulin glargin efter 26 ugers behandling.
- At sammenligne frekvensen af natlig hypoglykæmi (lavt blodsukker) på LY2605541 med insulin glargin i løbet af 26 ugers behandling.
- At sammenligne antallet af deltagere på LY2605541, der når blodsukkermålene uden hypoglykæmiepisoder om natten med dem, der tager insulin glargin efter 26 ugers behandling.
- At sammenligne frekvensen af hypoglykæmi over en 24-timers periode på LY2605541 med insulin glargin i løbet af 26 ugers behandling.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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New South Wales
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Camperdown, New South Wales, Australien, 2050
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St Leonards, New South Wales, Australien, 2065
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South Australia
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Daw Park, South Australia, Australien, 5041
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Victoria
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East Ringwood, Victoria, Australien, 3135
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Geelong, Victoria, Australien, 3220
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Parkville, Victoria, Australien, 3050
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Western Australia
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Fremantle, Western Australia, Australien, 6160
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Aparecida De Goiania, Brasilien, 74935530
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Brasilia, Brasilien, 71625-009
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Esbjerg, Danmark, 6700
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Hillerod, Danmark, 3400
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Kobenhavn, Danmark, 2400
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Arkhangelsk, Den Russiske Føderation, 163045
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Moscow, Den Russiske Føderation, 125367
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Rostov-On-Don, Den Russiske Føderation, 344022
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Saint Petersburg, Den Russiske Føderation, 198255
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Cleveland
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Middlesbrough, Cleveland, Det Forenede Kongerige, TS4 3BW
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Leicestershire
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Leicester, Leicestershire, Det Forenede Kongerige, LE5 4PW
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Scotland
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Edinburgh, Scotland, Det Forenede Kongerige, EH4 2XU
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Surrey
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Guildford, Surrey, Det Forenede Kongerige, GU2 7XX
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Alabama
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Mobile, Alabama, Forenede Stater, 36617
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
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California
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Anaheim, California, Forenede Stater, 92801
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Chino, California, Forenede Stater, 91710
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Concord, California, Forenede Stater, 94520
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Fresno, California, Forenede Stater, 93720
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La Mesa, California, Forenede Stater, 91942
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Lancaster, California, Forenede Stater, 93534
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Mission Hills, California, Forenede Stater, 91345
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Tustin, California, Forenede Stater, 92780
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Colorado
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Longmont, Colorado, Forenede Stater, 80501
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Florida
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Daytona Beach, Florida, Forenede Stater, 32117
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Jacksonville, Florida, Forenede Stater, 32204
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West Palm Beach, Florida, Forenede Stater, 33401
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Winter Haven, Florida, Forenede Stater, 33880
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
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Illinois
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Springfield, Illinois, Forenede Stater, 62704
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Iowa
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Des Moines, Iowa, Forenede Stater, 50314
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
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Maine
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Bangor, Maine, Forenede Stater, 04401
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Maryland
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Baltimore, Maryland, Forenede Stater, 21204
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Minnesota
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Eagan, Minnesota, Forenede Stater, 55123
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Missouri
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Jefferson City, Missouri, Forenede Stater, 65109
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Saint Louis, Missouri, Forenede Stater, 63141
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Montana
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Billings, Montana, Forenede Stater, 59101
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89148
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03063
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New Jersey
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Toms River, New Jersey, Forenede Stater, 08753
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New York
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New York, New York, Forenede Stater, 10025
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North Carolina
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Morehead City, North Carolina, Forenede Stater, 28557
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58103
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Ohio
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Cleveland, Ohio, Forenede Stater, 44122
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Columbus, Ohio, Forenede Stater, 43213
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Mentor, Ohio, Forenede Stater, 44060
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
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South Carolina
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Greer, South Carolina, Forenede Stater, 29651
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37411
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Memphis, Tennessee, Forenede Stater, 38119
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Texas
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Arlington, Texas, Forenede Stater, 76014
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Austin, Texas, Forenede Stater, 78731
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Dallas, Texas, Forenede Stater, 75231
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Washington
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Renton, Washington, Forenede Stater, 98057
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Spokane, Washington, Forenede Stater, 99202
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Tacoma, Washington, Forenede Stater, 98405
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Ampelokipoi, Grækenland, 11527
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Athens, Grækenland, 11527
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Nikaias - Piraeus, Grækenland, 18454
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Thessaloniki, Grækenland, 54639
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Dordrecht, Holland, 3317 NM
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Groningen, Holland, 9728 NT
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Heerlen, Holland, 6419 PC
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Hoogeveen, Holland, 7909AA
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Leiden, Holland, 2333 ZA
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Beer Sheva, Israel, 84101
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Holon, Israel, 58100
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Jerusalem, Israel, 91120
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Nahariya, Israel, 22100
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Safed, Israel, 13110
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Tel Hashomer, Israel, 52621
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Bergamo, Italien, 24128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bologna, Italien, 40138
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Olbia, Italien, 07026
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Pavia, Italien, 27100
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Rozzano, Italien, 20089
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Kanagawa, Japan, 235-0045
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Kumamoto, Japan, 862-0976
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Tokyo, Japan, 1030002
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Ankara, Kalkun, 06100
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Diyarbakir, Kalkun, 21280
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Istanbul, Kalkun, 34662
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Kayseri, Kalkun, 38039
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Kutahya, Kalkun, 43300
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Cakovec, Kroatien, 40000
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Osijek, Kroatien, 31000
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Rijeka, Kroatien, HR-51000
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Slavonski Brod, Kroatien, 35000
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Varazdin, Kroatien, 42000
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Zagreb, Kroatien, 10000
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Kaunas, Litauen, LT-48259
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Klaipeda, Litauen, 92304
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Monterrey, Mexico, 64460
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Queretaro, Mexico, 76000
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Tampico, Mexico, 89000
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Krakow, Polen, 31-455
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Lublin, Polen, 20-538
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Sopot, Polen, 81-756
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Szczecin, Polen, 70-506
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Wroclaw, Polen, 50-306
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Caguas, Puerto Rico, 00726
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Las Lomas, Puerto Rico, 00921
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Manati, Puerto Rico, 00674
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San Juan, Puerto Rico, 00917-3104
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Yabucoa, Puerto Rico, 00767
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Brasov, Rumænien, 500283
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Cluj, Rumænien, 400349
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Oradea, Rumænien, 410169
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Ploiesti, Rumænien, 100163
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Satu Mare, Rumænien, 440055
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Dolny Kubin, Slovakiet, 02601
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Kosice, Slovakiet, 04012
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Lubochna, Slovakiet, 03491
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Roznava, Slovakiet, 048 01
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Barcelona, Spanien, 08035
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Málaga, Spanien, 29010
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Sabadell, Spanien, 08208
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Sevilla, Spanien, 41010
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Seville, Spanien, 41003
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Chiayi City, Taiwan, 600
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Sindian City, Taiwan, 23148
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Taichung, Taiwan, 404
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Yong Kung City, Taiwan, 71004
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Holesov, Tjekkiet, 769 01
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Hranice I-Mesto, Tjekkiet, 753 01
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Krnov, Tjekkiet, 79401
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Pardubice, Tjekkiet, 53002
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Prague, Tjekkiet, 128 08
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Berlin, Tyskland, 10409
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Burghausen, Tyskland, 84489
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Eisenach, Tyskland, 99817
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Essen, Tyskland, 45355
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Falkensee, Tyskland, 14612
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Mainz, Tyskland, 55116
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Mayen, Tyskland, 56727
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Münster, Tyskland, 48153
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Neuwied, Tyskland, 56564
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Bekescsaba, Ungarn, 5600
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Budapest, Ungarn, 1212
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Gyula, Ungarn, 5700
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Veszprem, Ungarn, 8200
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Zalaegerszeg, Ungarn, 8900
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Graz, Østrig, 8036
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Vienna, Østrig, A1090
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier
- Har type 2 diabetes mellitus baseret på Verdenssundhedsorganisationens (WHO) klassifikation
- Havde diabetes ≥1 år
- Har en hæmoglobin A1c (HbA1c) værdi ≥7,0 % og <12,0 % ved screening
- Har et kropsmasseindeks (BMI) ≤45,0 kilogram pr. kvadratmeter (kg/m^2)
- Deltagere på enhver glukosesænkende kur, der indeholder mindst 1 daglig insulininjektion
Dette inklusionskriterium gælder KUN for kvinder i den fødedygtige alder
- ikke ammer
- Test negativ for graviditet ved screening og randomisering
- Har ikke til hensigt at blive gravid under undersøgelsen
- Har praktiseret en pålidelig præventionsmetode i mindst 6 uger før screening
- Accepter at fortsætte med at bruge en pålidelig præventionsmetode under undersøgelsen, som bestemt af investigator (og i 2 uger efter den sidste dosis af undersøgelseslægemidlet)
- Få adgang til en metode til kommunikation med webstedet
- Har køl i hjemmet
- Er i stand til og er villig til at gøre følgende: overholde en flerdobbelt daglig injektionsregime, injicere insulin med et tildækket hætteglas og sprøjte og fyldt pen, deltage i nogle aftaler i fastende tilstand og udføre egen blodsukkerovervågning og journalføring efter behov denne protokol, som bestemt af efterforskeren. Pårørende kan være ansvarlig for alt ovenstående
- Har givet skriftligt informeret samtykke til at deltage i denne undersøgelse i overensstemmelse med lokale regler
Eksklusionskriterier
- Kontinuerlig subkutan insulininfusionsbehandling før screening
- Bruger insulin glargin to gange dagligt før screening
- Overdreven insulinresistens defineret som at have modtaget en daglig dosis insulin ≥2,0 enheder pr. kilogram (enheder/kg) på tidspunktet for præ-randomisering
- Glucagon-lignende peptid-1 (GLP-1) receptoragonist (f.eks. exenatid, exenatid en gang om ugen eller liraglutid), thiazolidindion (rosiglitazon, pioglitazon) eller pramlintid, der anvendes samtidigt eller inden for 90 dage før screening
- Bruger niacinpræparater som lipidsænkende medicin og/eller galdesyrebindende midler inden for 90 dage før screening; eller bruger lipidsænkende medicin i en dosis, der ikke har været stabil i ≥90 dage før screening
- Har fastende hypertriglyceridæmi (defineret som >4,5 millimol pr. liter [mmol/L], >400 milligram pr. deciliter [mg/dL]) ved screening
- Tager i øjeblikket eller har taget inden for de 90 dage forud for screening, receptpligtig eller håndkøbsmedicin til vægttab
- Har haft en episode med alvorlig hypoglykæmi (defineret som behov for assistance på grund af neurologisk invaliderende hypoglykæmi) inden for 6 måneder før indtræden i undersøgelsen
- Har haft 2 eller flere skadestuebesøg eller hospitalsindlæggelser på grund af dårlig glukosekontrol inden for de 6 måneder før screening
- Har haft 1 eller flere episoder af ketoacidose eller hyperosmolær tilstand/koma, der kræver indlæggelse inden for 6 måneder før screening
- Har hjertesygdom med funktionel status, der er New York Heart Association klasse III eller IV (i henhold til New York Heart Association Cardiac Disease Classification)
- Får i øjeblikket nyredialyse eller har en serumkreatinin ≥2,0 mg/dL, bortset fra deltagere, der tager metformin, som skal følge lokale mærkningsrestriktioner vedrørende metforminbrug og serumkreatinin
Har tydelige kliniske tegn eller symptomer på leversygdom (undtagen ikke-alkoholisk fedtleversygdom [NAFLD], akut eller kronisk hepatitis, ikke-alkoholisk steatohepatitis [NASH] eller forhøjede leverenzymmålinger som angivet nedenfor:
- total bilirubin ≥2X den øvre grænse for normal (ULN) som defineret af centrallaboratoriet, eller
- alanin aminotransferase (ALT)/serum glutamin pyrodruevin transaminase (SGPT) >2,5X ULN som defineret af centrallaboratoriet, eller
- aspartat aminotransferase (AST)/serum glutaminsyre oxaloeddikesyre transaminase (SGOT) >2,5X ULN som defineret af centrallaboratoriet
- Har aktiv eller ubehandlet malignitet, har været i remission fra klinisk signifikant malignitet (bortset fra basalcelle- eller planocellulær hudcancer) i mindre end 5 år, eller har øget risiko for at udvikle cancer eller recidiv af cancer efter investigators mening
- Har kendt eller udviklet overfølsomhed eller allergi over for nogen af undersøgelsesinsulinerne eller deres hjælpestoffer
- Har haft en blodtransfusion eller alvorligt blodtab inden for 3 måneder før screening eller har kendt hæmoglobinopati, hæmolytisk anæmi eller seglcelleanæmi eller andre træk ved hæmoglobin-abnormiteter, der vides at interferere med HbA1c-målingen
- Modtager kronisk (varig længere end 14 dage i træk) systemisk glukokortikoidbehandling (undtagen topiske, intraokulære, intranasale og inhalerede præparater) eller har modtaget en sådan behandling inden for 8 uger umiddelbart før screening med undtagelse af substitutionsterapi for binyrebarkinsufficiens
- Diagnosticeret klinisk signifikant diabetisk autonom neuropati, efter investigators mening
- Har fået en organtransplantation
- Har en anden tilstand (herunder kendt stof- eller alkoholmisbrug eller psykiatrisk lidelse, herunder spiseforstyrrelse), der forhindrer deltageren i at følge og udfylde protokollen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: FIDOBELT
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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ACTIVE_COMPARATOR: Insulin Glargine + Insulin Lispro
Deltagerspecifik dosis af Insulin Glargine vil blive administreret subkutant (SC) én gang dagligt ved sengetid i 26 uger. Deltagerspecifik dosis af Insulin Lispro vil blive administreret SC til præprandial (før måltid) og supplerende doser i 26 uger. |
Andre navne:
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EKSPERIMENTEL: LY2605541 + Insulin Lispro
Deltagerspecifik dosis af LY2605541 vil blive administreret SC én gang dagligt ved sengetid i 26 uger. Deltagerspecifik dosis af Insulin Lispro vil blive administreret SC til præprandiale og supplerende doser i 26 uger. |
Andre navne:
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring fra baseline i hæmoglobin A1c (HbA1c) efter 26 uger
Tidsramme: Baseline, 26 uger
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HbA1c er en test, der måler en deltagers gennemsnitlige blodsukkerniveau over en tidsramme på 2 til 3 måneder.
Mindste kvadraters (LS)-middelværdier blev beregnet ved hjælp af mixed model repeated measurements (MMRM) justering for stratifikationsfaktorer (land, low-density lipoprotein kolesterol [LDL-C, <100 milligram pr. deciliter (mg/dL) og ≥100 mg/dL] og antal insulininjektioner ved baseline [1, 2 eller ≥3]), besøg, behandling, besøg-for-behandling interaktion og baseline HbA1c.
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Baseline, 26 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hypoglykæmi i alt (justeret i 30 dage)
Tidsramme: Baseline gennem 26 uger
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Hypoglykæmiske episoder er defineret som hændelser, der er forbundet med rapporterede tegn og symptomer på hypoglykæmi og/eller dokumenterede blodsukkerkoncentrationer (BG) på ≤70 mg/dL (3,9 millimol pr. liter [mmol/L]).
Gruppegennemsnitsrater for total hypoglykæmi (pr. 30 dage) er præsenteret og blev beregnet ud fra negative binomiale regressionsmodeller (antal episoder = behandling + baseline total hypoglykæmirate, med log [eksponering i dage/30] som en offsetvariabel).
Gruppegennemsnit estimeres ved først at tage den omvendte link-funktion på individuelle deltagerkovariater og derefter gennemsnit over alle deltagere.
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Baseline gennem 26 uger
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Procentdel af deltagere med total hypoglykæmiepisoder
Tidsramme: Baseline gennem 26 uger
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Hypoglykæmiske episoder er defineret som hændelser, der er forbundet med rapporterede tegn og symptomer på hypoglykæmi og/eller dokumenterede BG-koncentrationer på ≤70 mg/dL (3,9 mmol/L).
Procentdelen af deltagere blev beregnet ved at dividere antallet af deltagere med hypoglykæmiske episoder med det samlede antal analyserede deltagere ganget med 100.
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Baseline gennem 26 uger
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Hypoglykæmi om natten (justeret i 30 dage)
Tidsramme: Baseline gennem 26 uger
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Hypoglykæmiske episoder defineres som hændelser, der er forbundet med rapporterede tegn og symptomer på hypoglykæmi og/eller en dokumenteret BG-koncentration på ≤70 mg/dL (3,9 mmol/L).
En natlig hypoglykæmisk hændelse opstod mellem sengetid og opvågning og mellem tidspunkterne 22:00 og 10:00.
Gruppegennemsnitsrater for natlig hypoglykæmi (pr. 30 dage) er præsenteret og blev beregnet ud fra negative binomiale regressionsmodeller (antal episoder = behandling + baseline natlig hypoglykæmirate, med log [eksponering i dage/30] som en offsetvariabel).
Gruppegennemsnit estimeres ved først at tage den omvendte link-funktion på individuelle deltagerkovariater og derefter gennemsnit over alle deltagere.
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Baseline gennem 26 uger
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Procentdel af deltagere med episoder med natlig hypoglykæmi
Tidsramme: Baseline gennem 26 uger
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Hypoglykæmiske episoder er defineret som en hændelse, der er forbundet med rapporterede tegn og symptomer på hypoglykæmi og/eller en BG-koncentration på ≤70 mg/dL (3,9 mmol/L).
En natlig hypoglykæmisk hændelse opstod mellem sengetid og opvågning og mellem tidspunkterne 22:00 og 10:00.
Procentdelen af deltagere blev beregnet ved at dividere antallet af deltagere med natlige hypoglykæmiske episoder med det samlede antal analyserede deltagere ganget med 100.
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Baseline gennem 26 uger
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Ændring af kropsvægt fra baseline til 26 uger
Tidsramme: Baseline, 26 uger
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LS-middelværdier blev beregnet ved hjælp af MMRM-justering for stratifikationsfaktorer (baseline HbA1c [≤8,5% og >8,5%], land, LDL-C [<100 mg/dL og ≥100 mg/dL] og antal insulininjektioner ved baseline [ 1, 2 eller ≥3]), behandling, besøg, behandling-for-besøg interaktion og baseline kropsvægt som faste effekter og deltager som en tilfældig effekt.
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Baseline, 26 uger
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Self-Monitored Blood Glucose (SMBG) 9-punktsprofiler ved 26 uger
Tidsramme: 26 uger
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9-punkts SMBG-profiler blev opnået over 2 ikke-på hinanden følgende dage inden for ugen forud for uge 0, 4, 12 og 26.
SMBG-målinger blev taget på 9 tidspunkter: før morgenmåltid, 2 timer efter morgenmåltid, før middagsmåltid, 2 timer efter middagsmåltid, før aftenmåltid, 2 timer efter aftenmåltid, sengetid, cirka kl. 0300 timer og den efterfølgende morgen før morgenmåltidet.
LS-middelværdier blev beregnet ved hjælp af MMRM-justering for stratifikationsfaktorer (baseline HbA1c [≤8,5% og >8,5%], land, LDL-C [<100 mg/dL og ≥100 mg/dL] og antal insulininjektioner ved baseline [ 1, 2 eller ≥3]), besøg, behandling, besøg-for-behandling interaktion og baseline BG-værdier.
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26 uger
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Procentdel af deltagere med HbA1c <7,0 % og ≤6,5 % efter 26 uger
Tidsramme: op til 26 uger
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Procentdelen af deltagere blev beregnet ved at dividere antallet af deltagere, der nåede målet HbA1c, med det samlede antal analyserede deltagere ganget med 100.
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op til 26 uger
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Procentdel af deltagere med HbA1c <7,0 % uden natlig hypoglykæmi efter 26 uger
Tidsramme: op til 26 uger
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Hypoglykæmiske episoder er defineret som en hændelse, der er forbundet med rapporterede tegn og symptomer på hypoglykæmi og/eller en dokumenteret blodsukkerkoncentration på ≤70 mg/dL (3,9 mmol/L).
En natlig hypoglykæmisk hændelse opstod mellem sengetid og opvågning og mellem tidspunkterne 22:00 og 10:00.
Procentdelen af deltagere blev beregnet ved at dividere antallet af deltagere med HbA1c <7,0 % uden natlig hypoglykæmi med det samlede antal analyserede deltagere ganget med 100.
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op til 26 uger
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Basal-, bolus- og total insulindosis efter vægt efter 26 uger
Tidsramme: 26 uger
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Basal insulindosis, korttidsvirkende bolusinsulindosis (hvert måltid og samlet) og total insulindosis blev beregnet ud fra dosis i løbet af de sidste 7 dage før besøget efter behandling eller de sidste 3 dage før randomiseringsbesøget.
LS-middelværdier blev beregnet ved hjælp af en begrænset longitudinel dataanalyse (cLDA)-model, der justerede for indikatorvariabler for hver behandlingsgruppe ved hvert post-baseline-besøg og stratificeringsvariabler (baseline HbA1c [≤8,5% og >8,5%], land, baseline LDL-C [<100 mg/dL og ≥100 mg/dL] og baseline antal af insulininjektioner [1, 2 eller ≥3]).
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26 uger
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Fastende serumglukose (FSG) fra laboratoriet ved 26 uger
Tidsramme: 26 uger
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LS-middelværdier blev beregnet ved hjælp af MMRM-justering for stratifikationsfaktorer (baseline HbA1c [≤8,5% og >8,5%], land, LDL-C [<100 mg/dL og ≥100 mg/dL] og antal insulininjektioner ved baseline [ 1, 2 eller ≥3]), behandling, besøg, behandling-for-besøg interaktion og baseline FSG.
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26 uger
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Fastende blodsukker (FBG) (af SMBG) Variabilitet mellem deltagere efter 26 uger
Tidsramme: 26 uger
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FBG blev målt ved selvmonitoreret blodsukker (SMBG).
Glucosevariabilitet mellem dage måles ved standardafvigelsen af FBG.
LS-middelværdier blev beregnet ved hjælp af MMRM-justering for stratifikationsfaktorerne (baseline HbA1c [≤8,5% og >8,5%], land, baseline LDL-C [<100 mg/dL og ≥100 mg/dL] og antal insulininjektioner kl. baseline [1, 2 eller ≥3]), behandling, besøg, behandling-for-besøg interaktion og baseline FBG-variabilitet.
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26 uger
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0300-timers blodsukker til FBG-udflugt ved 26 uger
Tidsramme: 26 uger
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Resultaterne af en 0300-timers til før-morgen-måltid (FBG)-udflugt er præsenteret (kun SMBG-profiler med både 0300-timer og den næste dag før-morgen-målinger er inkluderet til beregning af en sådan udflugt).
LS-middelværdier blev beregnet ved hjælp af MMRM-justering for stratifikationsfaktorer (baseline HbA1c [≤8,5% og >8,5%], land, baseline LDL-C [<100 mg/dL og ≥100 mg/dL] og antal insulininjektioner ved baseline [1, 2 eller ≥3]), behandling, besøg, behandling-for-besøg-interaktion og baseline-udflugt.
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26 uger
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HbA1c efter 26 uger
Tidsramme: 26 uger
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HbA1c er en test, der måler en deltagers gennemsnitlige blodsukkerniveau over de seneste 2 til 3 måneder.
LS-middelværdier blev beregnet ved hjælp af MMRM-justering for stratifikationsfaktorer (land, LDL-C [<100 mg/dL og ≥100 mg/dL] og antal insulininjektioner ved baseline [1, 2 eller ≥3]), behandling, besøg, behandling, besøg-for-behandling interaktion og baseline HbA1c.
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26 uger
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Lipidprofil ved 26 uger
Tidsramme: 26 uger
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Koncentrationer af kolesterol, højdensitetslipoproteinkolesterol (HDL-C), LDL-C og triglycerider er opsummeret.
LS-middelværdier blev beregnet ved hjælp af MMRM-justering for stratifikationsfaktorer (baseline HbA1c [≤8,5 % og >8,5 %], land, LDL-C [<100 mg/dL og ≥100 mg/dL], bortset fra LDL-C-udfaldsvariablen ], antal insulininjektioner ved baseline [1, 2 eller ≥3]), besøg, behandling, besøg-for-behandling interaktion og baseline værdi af tilsvarende lipid udfaldsvariabel.
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26 uger
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Antal deltagere med ændring i anti-LY2605541 antistoffer fra baseline til 26 uger
Tidsramme: Baseline gennem 26 uger
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Antallet af deltagere med et behandlingsudløst anti-LY2605541 antistofrespons (TEAR) er opsummeret.
TEAR er defineret som ændring fra baseline til post-baseline i anti-LY2605541-antistofniveauet enten fra upåviselig til påviselig eller fra påviselig til værdien med mindst 130 % relativ stigning fra baseline.
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Baseline gennem 26 uger
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Insulin Treatment Satisfaction Questionnaire (ITSQ) efter 26 uger
Tidsramme: op til 26 uger
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ITSQ er et valideret instrument, der indeholder 22 punkter, der vurderer behandlingstilfredshed for deltagere med diabetes og insulin.
Spørgeskemaet måler tilfredshed fra følgende 5 domæner: Besvær ved kur, livsstilsfleksibilitet, glykæmisk kontrol, hypoglykæmisk kontrol, insulinindføringsanordning.
Data præsenteret er den transformerede overordnede score på en skala fra 0-100, hvor højere score indikerer bedre behandlingstilfredshed.
LS-middelværdier blev beregnet ved hjælp af en analyse af kovariansmodel (ANCOVA) med behandlings- og stratificeringsfaktorer (baseline HbA1c [≤8,5 % og >8,5 %], land og baseline antal insulininjektioner [1, 2 eller ≥3]) som faste effekter og basislinjeværdi af ITSQ-scorerne som en kovariat.
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op til 26 uger
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Lavt blodsukkerundersøgelse (LBSS) efter 26 uger
Tidsramme: 26 uger
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LBSS (også omtalt som Hypoglykæmi Fear Survey - II [HFS-II]) er et spørgeskema med 33 punkter, der måler 1) adfærd for at undgå hypoglykæmi og dens negative konsekvenser (15 punkter) og 2) bekymringer om hypoglykæmi og dens negative konsekvenser (18 genstande).
Svarene er lavet på en 5-punkts Likert-skala, hvor 0 = Aldrig og 4 = Altid.
Samlet score er summen af alle elementer (interval 0-132).
Højere totalscore afspejler større frygt for hypoglykæmi.
LS-middelværdier blev beregnet ved hjælp af MMRM inklusive stratifikationsfaktorer (baseline HbA1c [≤8,5% og >8,5%], land, baseline antal insulininjektioner [1, 2 eller ≥3]), besøg, behandling, besøg-for-behandling interaktion og baseline LBSS-score.
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26 uger
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EuroQoL-5D (EQ-5D) efter 26 uger
Tidsramme: op til 26 uger
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EQ-5D er et generisk, multidimensionelt, sundhedsrelateret livskvalitetsinstrument.
Profilen giver deltagerne mulighed for at vurdere deres helbredstilstand i 5 sundhedsdomæner: mobilitet, egenomsorg, sædvanlige aktiviteter, smerter/ubehag og angst/depression ved hjælp af en tre niveaus skala fra 1-3 (ingen problem, nogle problemer og ekstreme problemer ).
Disse kombinationer af attributter konverteres til en vægtet sundhedstilstandsindeksscore i henhold til USA's befolkningsbaserede algoritme.
Score varierer fra -0,11 til 1,0, hvor en score på 1,0 indikerer perfekt helbred.
LS-middelværdier blev beregnet ved hjælp af ANCOVA-justering for behandling, stratifikationsfaktorer (baseline HbA1c [≤8,5% og >8,5%], land og baseline antal af insulininjektioner [1, 2 eller ≥ 3]) og baseline EQ-5D-score .
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op til 26 uger
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Hurtig vurdering af fysisk aktivitet (RAPA) efter 26 uger
Tidsramme: op til 26 uger
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RAPA-spørgeskemaet vurderer niveauet og intensiteten af fysisk aktivitet hos voksne deltagere.
Den indeholder 2 underskalaer: RAPA 1 (aerob) og RAPA 2 (styrke og fleksibilitet).
RAPA 1 indeholder 7 spørgsmål vedrørende deltagerens mængde og intensitet af fysisk aktivitet, hvilket gør det muligt for hver deltagers aerobe aktivitetsniveau at blive kategoriseret som stillesiddende, underaktive, lette aktiviteter, let aktivitet, almindelig underaktiv eller aktiv.
RAPA 2 indeholder 2 spørgsmål vedrørende deltagernes fysiske aktiviteter, der øger styrken og forbedrer fleksibiliteten.
Hver deltagers styrke- og smidighedsaktivitetsniveau kategoriseres derefter som hverken styrke- eller smidighedsaktivitet, hverken styrke- eller smidighedsaktivitet (ikke begge dele), både styrke- og smidighedsaktivitet.
Procentdelen af deltagere i hver RAPA 1/2-kategori præsenteres og blev beregnet ved at dividere antallet af deltagere i hver RAPA 1/2-kategori med det samlede antal analyserede deltagere ganget med 100.
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op til 26 uger
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (FAKTISKE)
Studieafslutning (FAKTISKE)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (SKØN)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (FAKTISKE)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12145
- I2R-MC-BIAM (ANDET: Eli Lilly and Company)
- 2011-001254-29 (EUDRACT_NUMBER)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diabetes mellitus, type 2
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Instituto Nacional de Ciencias Medicas y Nutricion...Aktiv, ikke rekrutterende
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Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes | Type 2 diabetes mellitus (T2DM) | Type 2 Diabetes
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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi... og andre samarbejdspartnereIkke rekrutterer endnuType 2 diabetes | Diabetes mellitus type 2Tyrkiet (Türkiye)
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Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes mellitus | Type 2 diabetes | Type 2 diabetes
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University Hospital Inselspital, BerneAfsluttetType 2 diabetes mellitusSchweiz
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India Diabetes Research Foundation & Dr. A. Ramachandran...Afsluttet
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El Katib HospitalIkke rekrutterer endnuType 2 diabetes mellitus (T2DM)
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He Eye HospitalIkke rekrutterer endnu
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Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectRekrutteringType 2 diabetes mellitus (T2DM)Forenede Stater
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Global Institute of Stem Cell Therapy and ResearchIkke rekrutterer endnu
Kliniske forsøg med Insulin Glargine
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SanofiAfsluttet
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Johns Hopkins UniversityAfsluttetHypoglykæmi | Type 1 diabetesForenede Stater
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IRCCS San RaffaeleAfsluttetType 2 diabetes mellitus | Perifer vaskulær sygdomItalien
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SanofiAfsluttetDiabetes mellitus type 2Tyskland
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Novo Nordisk A/SAfsluttetDiabetes mellitus, type 2Tyskland
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SanofiAfsluttetType 1 diabetes mellitusForenede Stater, Canada, Tjekkiet, Danmark, Estland, Finland, Ungarn, Japan, Letland, Holland, Puerto Rico, Rumænien, Sverige
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SanofiAfsluttet
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SanofiAfsluttetType 2 diabetes mellitusForenede Stater, Sydafrika, Canada, Tjekkiet, Estland, Finland, Frankrig, Tyskland, Ungarn, Letland, Mexico, Holland, Rumænien
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SanofiAfsluttetType 2 diabetes mellitusForenede Stater, Finland, Sydafrika, Canada, Mexico, Chile, Spanien, Den Russiske Føderation, Frankrig, Tyskland, Ungarn, Portugal, Rumænien