558
Participants
Start Date
June 30, 2014
Primary Completion Date
July 31, 2016
Study Completion Date
July 31, 2016
Mylan's insulin glargine
All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
Lantus®
All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
Mylan Investigational Site, Budapest
Mylan Investigational Site, Budapest
Mylan Investigational Site, Budapest
Mylan Investigational Site, Johannesburg
Mylan Investigational Site, Johannesburg
Mylan Investigational Site, Krugersdorp
Mylan Investigational Site, Johannesburg
Mylan Investigational Site, Eger
Mylan Investigational Site, Miskolc
Mylan Investigational Site, Limbaži
Mylan Investigational Site, Durban
Mylan Investigational Site, Létavértes
Mylan Investigational Site, Gyula
Mylan Investigational Site, Baja
Mylan Investigational Site, Szeged
Mylan Investigational Site, Cape Town
Mylan Investigational Site, Cape Town
Mylan Investigational Site, Cape Town
Mylan Investigational Site, Bloemfontein
Mylan Investigational Site, Staten Island
Mylan Investigational Site, Mineola
Mylan Investigational Site, Albany
Mylan Investigational Site, Syracuse
Mylan Investigational Site, Tallinn
Mylan Investigational Site, Manassas
Mylan Investigational Site, Hamburg
Mylan Investigational Site, Hamburg
Mylan Investigational Site, Chesapeake
Mylan Investigational Site, Burlington
Mylan Investigational Site, Greensboro
Mylan Investigational Site, Greenville
Mylan Investigational Site, Wilmington
Mylan Investigational Site, Morehead City
Mylan Investigational Site, Hickory
Mylan Investigational Site, Asheville
Mylan Investigational Site, Atlanta
Mylan Investigational Site, Columbus
Mylan Investigational Site, Hialeah
Mylan Investigational Site, Hollywood
Mylan Investigational Site, Cooper City
Mylan Investigational Site, Miami
Mylan Investigational Site, Miami
Mylan Investigational Site, West Palm Beach
Mylan Investigational Site, Bradenton
Mylan Investigational Site, New Port Richey
Mylan Investigational Site, Palm Harbor
Mylan Investigational Site, Chattanooga
Mylan Investigational Site, Memphis
Mylan Investigational Site, Lexington
Mylan Investigational Site, Mentor
Mylan Investigational Site, Cincinnati
Mylan Investigational Site, Anderson
Mylan Investigational Site, Muncie
Mylan Investigational Site, Münster
Mylan Investigational Site, Des Moines
Mylan Investigational Site, Tartu
Mylan Investigational Site, Council Bluffs
Mylan Investigational Site, Broumov
Mylan Investigational Site, Billings
Mylan Investigational Site, Crystal Lake
Mylan Investigational Site, LaGrange
Mylan Investigational Site, Frankfurt am Main
Mylan Investigational Site, Springfield
Mylan Investigational Site, Aschaffenburg
Mylan Investigational Site, Overland Park
Mylan Investigational Site, Sankt Ingbert
Mylan Investigational Site, Topeka
Mylan Investigational Site, Omaha
Mylan Investigational Site, Omaha
Mylan Investigational Site, Dallas
Mylan Investigational Site, Olomouc
Mylan Investigational Site, San Antonio
Mylan Investigational Site, Round Rock
Texas Diabetes & Endocrinology, Round Rock
Mylan Investigational Site, Austin
Mylan Investigational Site, El Paso
Mylan Investigational Site, Pärnu
Mylan Investigational Site, Bratislava
Mylan Investigational Site, Bratislava
Mylan Investigational Site, Idaho Falls
Mylan Investigational Site, South Jordan
Mylan Investigational Site, Salt Lake City
Mylan Investigational Site, Salt Lake City
Mylan Investigational Site, Salt Lake City
Mylan Investigational Site, Ogden
Mylan Investigational Site, Bratislava
Mylan Investigational Site, Wangen
Mylan Investigational Site, Las Vegas
Mylan Investigational Site, Bell Gardens
Mylan Investigational Site, Long Beach
Mylan Investigational Site, Skalica
Mylan Investigational Site, Northridge
Mylan Investigational Site, Mission Hills
Mylan Investigational Site, Nové Mesto nad Váhom
Mylan Investigational Site, La Mesa
Mylan Investigational Site, National City
Mylan Investigational Site, La Jolla
Mylan Investigational Site, Tustin
Mylan Investigational Site, Levice
Mylan Investigational Site, Fresno
Mylan Investigational Site, Greenbrae
Mylan Investigational Site, Nové Zámky
Mylan Investigational Site, Walnut Creek
Mylan Investigational Site, Los Gatos
Mylan Investigational Site, Honolulu
Mylan Investigational Site, Prievidza
Mylan Investigational Site, Corvallis
Mylan Investigational Site, Schweinfurt
Mylan Investigational Site, Banská Bystrica
Mylan Investigational Site, Bend
Mylan Investigational Site, Rimavská Sobota
Mylan Investigational Site, Renton
Mylan Investigational Site, Tacoma
Mylan Investigational Site, Vancouver
Mylan Investigational Site, Buzău
Mylan Investigational Site, Timișoara
Mylan Investigational Site, Cluj-Napoca
Mylan Investigational Site, Oradea
Mylan Investigational Site, Oradea
Mylan Investigational Site, Baia Mare
Mylan Investigational Site, Bacau
Mylan Investigational Site, Iași
Mylan Investigational Site, Galati
Mylan Investigational Site, Red Deer
Mylan Investigational Site, Vancouver
Mylan Investigational Site, Winnipeg
Mylan Investigational Site, Laval
Mylan Investigational Site, Mirabel
Mylan Investigational Site, Montreal
Mylan Investigational Site, Brno
Mylan Investigational Site, Brno
Mylan Investigational Site, Bruntál
Mylan Investigational Site, České Budějovice
Mylan Investigational Site, Pardubice
Mylan Investigational Site, Prague
Mylan Investigational Site, Prague
Mylan Investigational Site, Hohenmölsen
Mylan Investigational Site, Dresden
Mylan Investigational Site, Makó
Mylan Investigational Site, Kuldīga
Mylan Investigational Site, Ogre
Mylan Investigational Site, Riga
Mylan Investigational Site, Riga
Mylan Investigational Site, Riga
Mylan Investigational Site, Sigulda
Mylan Investigational Site, Talsi
Mylan Investigational Site, Bucharest
Mylan Investigational Site, Bucharest
Mylan Investigational Site, Bardejov
Mylan Investigational Site, Dolný Kubín
Mylan Investigational Site, Košice
Mylan Investigational Site, Ľubochňa
Mylan Investigational Site, Prešov
Mylan Investigational Site, Pruské
Mylan Investigational Site, Sabinov
Mylan Investigational Site, Štúrovo
Mylan Investigational Site, Trebišov
Mylan Investigational Site, Žilina
Mylan Investigational Site, Pretoria
Mylan Investigational Site, Plymouth
Mylan Investigational Site, Leicester
Mylan Investigational Site, Swansea
Lead Sponsor
Mylan GmbH
INDUSTRY
Mylan Inc.
INDUSTRY