A Study in Patients With Type 2 Diabetes Mellitus (IMAGINE 2)

March 16, 2018 updated by: Eli Lilly and Company

A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study

The purpose of this study is:

  • To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
  • To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
  • To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
  • To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1188AAF
        • 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.
      • Caba, Argentina, 2000
        • 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.
      • Córdoba, Argentina, X5000BNB
        • 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.
      • Mar Del Plata, Argentina, B7600GNY
        • 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.
  • Australia
    • New South Wales
      • Merewether, New South Wales, Australia, 2291
        • 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.
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • 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.
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • 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.
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • 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.
  • Brazil
      • Marilia, Brazil, 17519-000
        • 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.
      • Rio De Janeiro, Brazil, 22271-100
        • 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.
      • Setor Oeste/Goiania, Brazil, 74100-120
        • 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.
      • São Paulo, Brazil, 04266-010
        • 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.
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • 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.
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • 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.
      • Victoria, British Columbia, Canada, V8V 3N7
        • 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.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3P 3P4
        • 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.
    • Ontario
      • Etobicoke, Ontario, Canada, M9R 4E1
        • 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.
      • Markham, Ontario, Canada, L6B 0P9
        • 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.
      • Toronto, Ontario, Canada, M9W 4L6
        • 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.
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • 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.
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • 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.
      • Sherbrooke, Quebec, Canada, J1G 5K2
        • 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.
  • Finland
      • Oulu, Finland, 90100
        • 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.
      • Seinajoki, Finland, 60220
        • 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.
  • Germany
      • Dippoldiswalde, Germany, 01744
        • 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.
      • Dresden, Germany, 01307
        • 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.
      • Friedrichsthal, Germany, 66299
        • 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.
      • Furth Im Wald, Germany, 93437
        • 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.
      • Goch, Germany, 47574
        • 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.
      • Hamburg, Germany, D-22587
        • 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.
      • Ludwigshafen, Germany, 67059
        • 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.
      • Münster, Germany, 48143
        • 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.
      • Saarbrücken, Germany, 66121
        • 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.
      • Schweinfurt, Germany, 97421
        • 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.
      • Sulzbach, Germany, 92237
        • 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.
  • Greece
      • Ampelokipoi, Greece, 11527
        • 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.
      • Athens, Greece, 11527
        • 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.
      • Thessaloniki, Greece, 56429
        • 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.
  • Hungary
      • Budapest, Hungary, H-1139
        • 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.
      • Debrecen, Hungary, 4032
        • 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.
      • Mako, Hungary, 6900
        • 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.
      • Salgotarjan, Hungary, 3100
        • 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.
      • Sopron, Hungary, 9400
        • 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.
  • Israel
      • Beer Sheva, Israel, 84350
        • 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.
      • Haifa, Israel, 35251
        • 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.
      • Raanana, Israel, 43452
        • 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.
  • Italy
      • Carpi, Italy, 41012
        • 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.
      • Castellanza, Italy, 21053
        • 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.
      • Foggia, Italy, 71100
        • 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.
      • Forli, Italy, 47100
        • 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.
      • Rome, Italy, 00133
        • 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.
      • Sesto San Giovanni, Italy, 20099
        • 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.
  • Lithuania
      • Utena, Lithuania, 28151
        • 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.
      • Vilnius, Lithuania, LT-08661
        • 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.
  • Mexico
      • Coatzacoalcos, Mexico, 96400
        • 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.
      • Mexico City, Mexico, 11550
        • 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.
      • Monterrey, Mexico, 64620
        • 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.
  • New Zealand
      • Auckland, New Zealand, 1640
        • 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.
  • Poland
      • Kamieniec Zabkowicki, Poland, 57-230
        • 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.
      • Katowice, Poland, 40-772
        • 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.
      • Krakow, Poland, 31-455
        • 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.
      • Lodz, Poland, 93-338
        • 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.
      • Ruda Slaska, Poland, 41-709
        • 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.
      • Szczecin, Poland, 70-506
        • 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.
      • Tychy, Poland, 43-100
        • 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.
      • Warsaw, Poland, 01-192
        • 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.
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • 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.
      • Manati, Puerto Rico, 00674
        • 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.
      • San Juan, Puerto Rico, 00917-3104
        • 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.
  • Romania
      • Bucharest, Romania, 011234
        • 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.
      • Cluj-Napoca, Romania, 400006
        • 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.
      • Iasi, Romania, 700547
        • 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.
      • Oradea, Romania, 410169
        • 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.
      • Ploiesti, Romania, 100342
        • 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.
      • Resita, Romania, 320076
        • 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.
      • Targu-Mures, Romania, 540098
        • 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.
  • Russian Federation
      • Cheboksary, Russian Federation, 428000
        • 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.
      • Kazan, Russian Federation, 420012
        • 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.
      • Kursk, Russian Federation, 303035
        • 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.
      • Novosibirsk, Russian Federation, 630091
        • 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.
      • Saint Petersburg, Russian Federation, 193257
        • 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.
  • Slovakia
      • Bratislava, Slovakia, 82102
        • 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.
      • Sala, Slovakia, 92701
        • 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.
      • Vranov Nad Toplou, Slovakia, 09301
        • 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.
  • South Africa
      • Paarl, South Africa, 7646
        • 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.
      • Parow, South Africa, 7505
        • 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.
      • Somerset West, South Africa, 7130
        • 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.
  • Spain
      • Alicante, Spain, 03114
        • 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.
      • Cordoba, Spain, 14004
        • 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.
      • Pozuelo De Alarcon, Spain, 28223
        • 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.
      • Requena, Spain, 46340
        • 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.
      • Seville, Spain, 41003
        • 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.
      • Toledo, Spain, 45004
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  • Turkey
      • Gaziantep, Turkey, 27070
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      • Hatay, Turkey, 31040
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      • Izmir, Turkey, 35340
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      • Kayseri, Turkey, 38039
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  • United Kingdom
    • Berks
      • Mortimer, Berks, United Kingdom, RG7 3SQ
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    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
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    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
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    • Wales
      • Swansea, Wales, United Kingdom, SA6 6NL
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  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
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      • Mobile, Alabama, United States, 36608
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    • Arizona
      • Chandler, Arizona, United States, 85224
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      • Mesa, Arizona, United States, 85206
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      • Tempe, Arizona, United States, 85283
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      • Tucson, Arizona, United States, 85704
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    • California
      • Concord, California, United States, 94520
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      • Escondido, California, United States, 92026
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      • Fresno, California, United States, 93720
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      • Greenbrae, California, United States, 94904
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      • Huntington Beach, California, United States, 92648
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      • Lancaster, California, United States, 93534
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      • Los Angeles, California, United States, 90057
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      • Mission Viejo, California, United States, 92691
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      • Northridge, California, United States, 91324
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      • Palm Springs, California, United States, 92262
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      • San Mateo, California, United States, 94401
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      • Tustin, California, United States, 92780
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    • Colorado
      • Denver, Colorado, United States, 80246
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    • Florida
      • Daytona Beach, Florida, United States, 32117
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      • Jacksonville, Florida, United States, 32258
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      • Tampa, Florida, United States, 33619
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      • Winter Haven, Florida, United States, 33880
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    • Georgia
      • Athens, Georgia, United States, 30606
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      • Atlanta, Georgia, United States, 30338
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      • Decatur, Georgia, United States, 30033
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    • Hawaii
      • Honolulu, Hawaii, United States, 96814
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    • Idaho
      • Idaho Falls, Idaho, United States, 83404
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      • Meridian, Idaho, United States, 83646
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    • Illinois
      • Chicago, Illinois, United States, 60607
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      • Springfield, Illinois, United States, 62704
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    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • 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.
    • Kansas
      • Topeka, Kansas, United States, 66606
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    • Louisiana
      • Shreveport, Louisiana, United States, 71103
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    • Maine
      • Bangor, Maine, United States, 04401
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    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
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    • Missouri
      • Saint Louis, Missouri, United States, 63141
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    • Montana
      • Billings, Montana, United States, 59102
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    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
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    • New Jersey
      • Toms River, New Jersey, United States, 08753
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    • Ohio
      • Cincinnati, Ohio, United States, 45236
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      • Gallipolis, Ohio, United States, 45631
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      • Perrysburg, Ohio, United States, 43551
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    • Oregon
      • Corvallis, Oregon, United States, 97330
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      • Springfield, Oregon, United States, 97477
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    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
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      • Downingtown, Pennsylvania, United States, 19335
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      • Lansdale, Pennsylvania, United States, 19446
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      • Levittown, Pennsylvania, United States, 19056
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      • Philadelphia, Pennsylvania, United States, 19107
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      • Pottstown, Pennsylvania, United States, 19464
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    • South Carolina
      • Greer, South Carolina, United States, 29651
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      • Myrtle Beach, South Carolina, United States, 29572
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    • Tennessee
      • Bristol, Tennessee, United States, 37620
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      • Knoxville, Tennessee, United States, 37912
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      • Memphis, Tennessee, United States, 38119
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      • Spring Hill, Tennessee, United States, 37174
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    • Texas
      • Austin, Texas, United States, 78758
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      • Marshall, Texas, United States, 75670
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      • Sugar Land, Texas, United States, 77478
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    • Utah
      • Bountiful, Utah, United States, 84010
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      • Clinton, Utah, United States, 84015
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      • Ogden, Utah, United States, 84403
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    • Washington
      • Olympia, Washington, United States, 98502
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      • Port Orchard, Washington, United States, 98366
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      • Spokane, Washington, United States, 99220
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
  • Have been receiving at least 2 OAMs for at least 3 months before entering the study
  • Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
  • Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
  • Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug

Exclusion Criteria:

  • Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
  • Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
  • Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
  • Have had any episodes of severe hypoglycemia within 6 months prior to screening
  • Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)
  • Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)
  • Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
  • Have active or untreated malignancy or have been in remission from clinically significant malignancy for less than 5 years
  • Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter [mmol/L]) at screening
  • Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
  • Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY2605541
LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
Drug: LY2605541
Active Comparator: Glargine
Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
Drug: Glargine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 52 weeks
HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol [LDL-C, < 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL] and sulfonylurea [SU]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
Baseline, 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Total and Nocturnal Hypoglycemia Events
Time Frame: Baseline to 52 weeks
Hypoglycemia is a condition that occurs when a person's blood glucose level is lower than the normal range (less than or equal to 70 milligrams per deciliter [mg/dL] or less than 3.9 millimoles per liter [mmol/L]). Total hypoglycemia refers to an event that meets the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemia refers to any total hypoglycemic event that occurs between bedtime and waking. Group mean (listed as LS means below) rates of total and nocturnal hypoglycemia were calculated using a negative binomial regression model (number of episodes = treatment + SU/meglitinide use + baseline hypoglycemia event rate, with log [exposure per 30 days] as the offset variable in the model).
Baseline to 52 weeks
Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %
Time Frame: 52 weeks
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
52 weeks
Fasting Serum Glucose (By Laboratory Measurement)
Time Frame: 52 weeks
LS means were calculated using a MMRM with baseline fasting serum glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
52 weeks
Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)
Time Frame: 52 weeks
LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
52 weeks
6 Point Self-monitored Blood Glucose (SMBG)
Time Frame: 52 weeks
Six-point SMBG profiles were obtained at pre-morning meal (fasting), pre-midday meal (lunch), pre-evening meal (dinner), bedtime, approximately 0300 hours, and pre-morning meal (fasting) the next day. Six-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to the next office visit. LS means were calculated using a MMRM with baseline blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
52 weeks
Change From Baseline to 52 Weeks in Body Weight
Time Frame: Baseline, 52 weeks
LS means were calculated using a MMRM with baseline body weight measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Baseline, 52 weeks
Hemoglobin A1c
Time Frame: 52 weeks
HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
52 weeks
Insulin Dose Per Body Weight
Time Frame: 52 weeks
LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
52 weeks
Number of Insulin Dose Adjustments to Steady-State
Time Frame: Baseline to 52 weeks
Insulin doses were adjusted according to an algorithm (adapted from Riddle et al. 2003) during the first 26 weeks of the study and thereafter according to investigator judgment. Steady-state was defined as the first local maximum dose (maximum of moving 4-week interval) of LY2605541 or glargine within the window of +/- 2 weeks. The number of dose adjustments to steady-state was the total number of dose changes until steady-state was reached. LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Baseline to 52 weeks
European Quality of Life-5 Dimension (EQ-5D)
Time Frame: 52 weeks
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using a MMRM with baseline stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
52 weeks
Insulin Treatment Satisfaction Questionnaire
Time Frame: Up to 52 weeks
The Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes who are receiving insulin. The questionnaire measures satisfaction from the following 5 domains: inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Data presented are the transformed total score on a scale of 0 to 100, where higher scores indicate better treatment satisfaction. LS means were calculated using a MMRM with stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Up to 52 weeks
Adult Low Blood Sugar Survey
Time Frame: Up to 52 weeks
The adult Low Blood Sugar Survey (LBSS) is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 4 = always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range of 0 to 132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using an analysis of covariance model (ANCOVA) with baseline LBSS score, stratification factors (country, HbA1c, and SU/meglitinide use), and treatment as fixed effects.
Up to 52 weeks
Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline, 52 weeks
LS means were calculated using a MMRM with baseline lipid measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Baseline, 52 weeks
Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
Time Frame: Up to 52 weeks
Up to 52 weeks
Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
Time Frame: Baseline to 78 weeks
The percentage of participants with a TEAR is summarized. TEAR is defined as a change in the anti-LY2605541 antibody level from undetectable at baseline to detectable at baseline, or, for those participants with detectable antibodies at baseline, change to a value with at least a 130% relative increase from baseline. Overall TEAR is defined as one or more TEAR during the specified period.
Baseline to 78 weeks
Intra-participant Variability of the Fasting Blood Glucose (FBG)
Time Frame: 52 weeks
Intra-participant variability of FBG, which was measured by SMBG, was assessed by the standard deviation of the FBG measurement at the Week 52 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
52 weeks
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Time Frame: Baseline to 52 weeks
A hypoglycemic event is defined by a blood glucose value ≤70 mg/dL (3.9mmol/L). Total hypoglycemic events include documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemic events refer to any total hypoglycemic event that occurs between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic or nocturnal hypoglycemic events by the total number of participants analyzed, multiplied by 100.
Baseline to 52 weeks
Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
Time Frame: Up to 52 weeks
The percentage of participants with HbA1C ≤ 6.5% or < 7.0% without nocturnal hypoglycemia is presented. Percentage was calculated by dividing the number of participants with the indicated HbA1c values over the total number of participants and multiplying by 100.
Up to 52 weeks
Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
Time Frame: Up to 52 weeks
The percentage of participants was calculated by dividing the number of participants equal or above 2- or 3-fold ULN for ALT/SGPT or AST/SGOT by the total number of participants analyzed, multiplied by 100.
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 9, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 16, 2011

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12141
  • I2R-MC-BIAJ (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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