AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3IMAGINE 2NCT01435616

A Study in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Glargine and LY2605541 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 167 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Glargine and LY2605541
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,538 participants
Where
167 sitesin 23 countries
Study dates
Nov 2011to Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

167 sites in 23 countries.

167 sites in 23 countries

United States66 sites

  • 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.

    Anniston, Alabama, 36207

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    Athens, Georgia, 30606

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    Atlanta, Georgia, 30338

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    Austin, Texas, 78758

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    Bangor, Maine, 04401

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    Beaver, Pennsylvania, 15009

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    Billings, Montana, 59102

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    Bountiful, Utah, 84010

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    Bristol, Tennessee, 37620

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    Chandler, Arizona, 85224

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    Chicago, Illinois, 60607

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    Cincinnati, Ohio, 45236

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    Clinton, Utah, 84015

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    Concord, California, 94520

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    Corvallis, Oregon, 97330

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    Daytona Beach, Florida, 32117

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    Decatur, Georgia, 30033

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    Denver, Colorado, 80246

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    Downingtown, Pennsylvania, 19335

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    Escondido, California, 92026

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    Fresno, California, 93720

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    Gallipolis, Ohio, 45631

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    Greenbrae, California, 94904

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    Greer, South Carolina, 29651

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    Haverhill, Massachusetts, 01830

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    Honolulu, Hawaii, 96814

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    Huntington Beach, California, 92648

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    Idaho Falls, Idaho, 83404

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    Jacksonville, Florida, 32258

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    Knoxville, Tennessee, 37912

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    Lancaster, California, 93534

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    Lansdale, Pennsylvania, 19446

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    Levittown, Pennsylvania, 19056

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    Los Angeles, California, 90057

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    Marshall, Texas, 75670

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    Memphis, Tennessee, 38119

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    Meridian, Idaho, 83646

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    Mesa, Arizona, 85206

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    Mission Viejo, California, 92691

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    Mobile, Alabama, 36608

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    Myrtle Beach, South Carolina, 29572

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    Nashua, New Hampshire, 03063

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    Northridge, California, 91324

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    Ogden, Utah, 84403

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    Olympia, Washington, 98502

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    Palm Springs, California, 92262

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    Perrysburg, Ohio, 43551

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    Philadelphia, Pennsylvania, 19107

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    Port Orchard, Washington, 98366

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    Pottstown, Pennsylvania, 19464

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    San Mateo, California, 94401

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    Shreveport, Louisiana, 71103

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    Spokane, Washington, 99220

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    Spring Hill, Tennessee, 37174

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    Springfield, Illinois, 62704

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    Springfield, Oregon, 97477

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    St Louis, Missouri, 63141

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    Sugar Land, Texas, 77478

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    Tampa, Florida, 33619

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    Tempe, Arizona, 85283

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    Toms River, New Jersey, 08753

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    Topeka, Kansas, 66606

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    Tucson, Arizona, 85704

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    Tustin, California, 92780

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    West Des Moines, Iowa, 50266

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    Winter Haven, Florida, 33880

Other trials in United States

Germany11 sites

  • 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.

    Dippoldiswalde, 01744

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    Dresden, 01307

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    Friedrichsthal, 66299

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    Furth im Wald, 93437

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    Goch, 47574

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    Hamburg, D-22587

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    Ludwigshafen, 67059

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    Münster, 48143

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    Saarbrücken, 66121

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    Schweinfurt, 97421

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    Sulzbach, 92237

Other trials in Germany

Canada10 sites

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    Edmonton, Alberta, T5J 3N4

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    Etobicoke, Ontario, M9R 4E1

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    Kelowna, British Columbia, V1Y 1Z9

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    Laval, Quebec, H7T 2P5

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    Markham, Ontario, L6B 0P9

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    Pointe-Claire, Quebec, H9R 4S3

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    Sherbrooke, Quebec, J1G 5K2

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    Toronto, Ontario, M9W 4L6

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    Victoria, British Columbia, V8V 3N7

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    Winnipeg, Manitoba, R3P 3P4

Other trials in Canada

Poland8 sites

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    Kamieniec Ząbkowicki, 57-230

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    Katowice, 40-772

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    Krakow, 31-455

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    Lodz, 93-338

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    Ruda Śląska, 41-709

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    Szczecin, 70-506

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    Tychy, 43-100

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    Warsaw, 01-192

Other trials in Poland

Romania7 sites

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    Bucharest, 011234

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    Cluj-Napoca, 400006

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    Iași, 700547

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    Oradea, 410169

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    Ploieşti, 100342

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    Reşiţa, 320076

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    Târgu Mureş, 540098

Other trials in Romania

Italy6 sites

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    Carpi, 41012

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    Castellanza, 21053

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    Foggia, 71100

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    Forlì, 47100

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    Rome, 00133

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    Sesto San Giovanni, 20099

Other trials in Italy

Spain6 sites

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    Alicante, 03114

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    Córdoba, 14004

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    Pozuelo de Alarcón, 28223

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    Requena, 46340

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    Seville, 41003

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    Toledo, 45004

Other trials in Spain

Hungary5 sites

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    Budapest, H-1139

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    Debrecen, 4032

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    Makó, 6900

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    Salgótarján, 3100

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    Sopron, 9400

Other trials in Hungary

Russia5 sites

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    Cheboksary, 428000

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    Kazan', 420012

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    Kursk, 303035

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    Novosibirsk, 630091

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    Saint Petersburg, 193257

Other trials in Russia

Argentina4 sites

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    Buenos Aires, C1188AAF

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    Caba, 2000

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    Córdoba, X5000BNB

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    Mar del Plata, B7600GNY

Other trials in Argentina

Australia4 sites

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    Box Hill, Victoria, 3128

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    Fremantle, Western Australia, 6160

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    Keswick, South Australia, 5035

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    Merewether, New South Wales, 2291

Other trials in Australia

Brazil4 sites

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    Marília, 17519-000

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    Rio de Janeiro, 22271-100

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    São Paulo, 04266-010

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    Setor Oeste/Goiania, 74100-120

Other trials in Brazil

Turkey (Türkiye)4 sites

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    Gaziantep, 27070

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    Hatay, 31040

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    Izmir, 35340

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    Kayseri, 38039

Other trials in Turkey (Türkiye)

United Kingdom4 sites

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    Guildford, Surrey, GU2 7XX

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    Leicester, Leicestershire, LE5 4PW

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    Mortimer, Berks, RG7 3SQ

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    Swansea, Wales, SA6 6NL

Other trials in United Kingdom

Greece3 sites

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    Ampelokipoi, 11527

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    Athens, 11527

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    Thessaloniki, 56429

Other trials in Greece

Israel3 sites

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    Beersheba, 84350

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    Haifa, 35251

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    Raanana, 43452

Other trials in Israel

Mexico3 sites

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    Coatzacoalcos, 96400

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    Mexico City, 11550

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    Monterrey, 64620

Other trials in Mexico

Puerto Rico3 sites

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    Hato Rey, 00917

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    Manati, 00674

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    San Juan, 00917-3104

Other trials in Puerto Rico

Slovakia3 sites

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    Bratislava, 82102

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    Šaľa, 92701

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    Vranov nad Topľou, 09301

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South Africa3 sites

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    Paarl, 7646

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    Parow, 7505

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    Somerset West, 7130

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Finland2 sites

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    Oulu, 90100

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    Seinäjoki, 60220

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Lithuania2 sites

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    Utena, 28151

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    Vilnius, LT-08661

Other trials in Lithuania

New Zealand1 site

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    Auckland, 1640

Other trials in New Zealand

About this study

Official title: 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
Being tested
Glargine, LY2605541
Keywords
diabetes mellitus, type 2 diabetes mellitus, insulin naive, insulin treatment
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlargineDrug

  • LY2605541Drug

Study groups in NCT01435616
Study groupRoleWhat they receive
LY2605541ExperimentalLY2605541 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
Receives: Drug: LY2605541
GlargineActive comparatorGlargine 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
Receives: Drug: Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)

    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.

    Measured: Baseline, 52 weeks

Secondary outcomes (19)

  1. Rate of Total and Nocturnal Hypoglycemia Events

    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).

    Measured: Baseline to 52 weeks

  2. Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %

    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.

    Measured: 52 weeks

  3. Fasting Serum Glucose (By Laboratory Measurement)

    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.

    Measured: 52 weeks

  4. Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)

    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.

    Measured: 52 weeks

  5. 6 Point Self-monitored Blood Glucose (SMBG)

    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.

    Measured: 52 weeks

  6. Change From Baseline to 52 Weeks in Body Weight

    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.

    Measured: Baseline, 52 weeks

  7. Hemoglobin A1c

    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.

    Measured: 52 weeks

  8. Insulin Dose Per Body Weight

    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.

    Measured: 52 weeks

  9. Number of Insulin Dose Adjustments to Steady-State

    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.

    Measured: Baseline to 52 weeks

  10. European Quality of Life-5 Dimension (EQ-5D)

    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.

    Measured: 52 weeks

  11. Insulin Treatment Satisfaction Questionnaire

    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.

    Measured: Up to 52 weeks

  12. Adult Low Blood Sugar Survey

    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.

    Measured: Up to 52 weeks

  13. Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)

    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.

    Measured: Baseline, 52 weeks

  14. Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin

    Measured: Up to 52 weeks

  15. Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)

    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.

    Measured: Baseline to 78 weeks

  16. Intra-participant Variability of the Fasting Blood Glucose (FBG)

    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.

    Measured: 52 weeks

  17. Percentage of Participants With Total and Nocturnal Hypoglycemic Events

    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.

    Measured: Baseline to 52 weeks

  18. Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia

    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.

    Measured: Up to 52 weeks

  19. 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)

    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.

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435616
Sponsor's protocol ID
12141
Other IDs
I2R-MC-BIAJ
Acronym
IMAGINE 2
Status last verified
Mar 2018
First submitted
9 Sep 2011
Last updated
13 Apr 2018
Data monitoring committee
Yes

Publications

  • Kunina H, Chien JY, Garhyan P, Geiser JS, Kjellsson MC. Blood-glucose Profile Evaluation with a Model-based Approach using Continuous Glucose Monitoring Data. AAPS J. 2026 May 6;28(3):97. doi: 10.1208/s12248-026-01245-8.

    PubMed 42091767

  • Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.

    PubMed 36542287

  • Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.

    PubMed 29167192

  • Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.

    PubMed 28587667

  • Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.

    PubMed 28417532

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glargine and LY2605541 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 167 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Germany, Canada, Poland, Romania and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01435616, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.

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