NCT01435616

Brief 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.
  • 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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,538

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2011

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
23 countries

167 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

April 13, 2018

Completed
Last Updated

April 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

September 9, 2011

Results QC Date

March 16, 2018

Last Update Submit

March 16, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitustype 2 diabetes mellitusinsulin naiveinsulin treatment

Outcome Measures

Primary Outcomes (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.

    Baseline, 52 weeks

Secondary Outcomes (19)

  • Rate of Total and Nocturnal Hypoglycemia Events

    Baseline to 52 weeks

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

    52 weeks

  • Fasting Serum Glucose (By Laboratory Measurement)

    52 weeks

  • Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)

    52 weeks

  • 6 Point Self-monitored Blood Glucose (SMBG)

    52 weeks

  • +14 more secondary outcomes

Study Arms (2)

LY2605541

EXPERIMENTAL

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

Glargine

ACTIVE COMPARATOR

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

Interventions

GlargineDRUG
Glargine
LY2605541DRUG
LY2605541

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (167)

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Anniston, Alabama, 36207, United States

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85206, United States

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Tempe, Arizona, 85283, United States

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Tucson, Arizona, 85704, United States

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Concord, California, 94520, United States

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Escondido, California, 92026, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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Huntington Beach, California, 92648, United States

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Lancaster, California, 93534, United States

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Los Angeles, California, 90057, United States

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Mission Viejo, California, 92691, United States

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Northridge, California, 91324, United States

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Palm Springs, California, 92262, United States

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San Mateo, California, 94401, United States

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Tustin, California, 92780, United States

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Denver, Colorado, 80246, United States

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Daytona Beach, Florida, 32117, United States

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Jacksonville, Florida, 32258, United States

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Tampa, Florida, 33619, United States

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Winter Haven, Florida, 33880, United States

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Athens, Georgia, 30606, United States

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Atlanta, Georgia, 30338, United States

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Decatur, Georgia, 30033, United States

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Honolulu, Hawaii, 96814, United States

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Idaho Falls, Idaho, 83404, United States

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Meridian, Idaho, 83646, United States

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Chicago, Illinois, 60607, United States

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Springfield, Illinois, 62704, United States

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West Des Moines, Iowa, 50266, United States

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Topeka, Kansas, 66606, United States

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Shreveport, Louisiana, 71103, United States

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Bangor, Maine, 04401, United States

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Haverhill, Massachusetts, 01830, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59102, United States

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Nashua, New Hampshire, 03063, United States

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Toms River, New Jersey, 08753, United States

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Cincinnati, Ohio, 45236, United States

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Gallipolis, Ohio, 45631, United States

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Perrysburg, Ohio, 43551, United States

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Corvallis, Oregon, 97330, United States

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Springfield, Oregon, 97477, United States

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Beaver, Pennsylvania, 15009, United States

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Downingtown, Pennsylvania, 19335, United States

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Lansdale, Pennsylvania, 19446, United States

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Levittown, Pennsylvania, 19056, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pottstown, Pennsylvania, 19464, United States

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Greer, South Carolina, 29651, United States

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Myrtle Beach, South Carolina, 29572, United States

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Bristol, Tennessee, 37620, United States

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Knoxville, Tennessee, 37912, United States

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Memphis, Tennessee, 38119, United States

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Spring Hill, Tennessee, 37174, United States

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Austin, Texas, 78758, United States

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Marshall, Texas, 75670, United States

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Sugar Land, Texas, 77478, United States

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Bountiful, Utah, 84010, United States

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Clinton, Utah, 84015, United States

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Ogden, Utah, 84403, United States

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Olympia, Washington, 98502, United States

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Port Orchard, Washington, 98366, United States

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Spokane, Washington, 99220, United States

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Buenos Aires, C1188AAF, Argentina

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Caba, 2000, Argentina

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Córdoba, X5000BNB, Argentina

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Mar del Plata, B7600GNY, Argentina

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Merewether, New South Wales, 2291, Australia

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Keswick, South Australia, 5035, Australia

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Box Hill, Victoria, 3128, Australia

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Fremantle, Western Australia, 6160, Australia

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Marília, 17519-000, Brazil

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Rio de Janeiro, 22271-100, Brazil

Location

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São Paulo, 04266-010, Brazil

Location

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Setor Oeste/Goiania, 74100-120, Brazil

Location

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Edmonton, Alberta, T5J 3N4, Canada

Location

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Kelowna, British Columbia, V1Y 1Z9, Canada

Location

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Victoria, British Columbia, V8V 3N7, Canada

Location

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Winnipeg, Manitoba, R3P 3P4, Canada

Location

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Etobicoke, Ontario, M9R 4E1, Canada

Location

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Markham, Ontario, L6B 0P9, Canada

Location

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Toronto, Ontario, M9W 4L6, Canada

Location

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Laval, Quebec, H7T 2P5, Canada

Location

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Pointe-Claire, Quebec, H9R 4S3, Canada

Location

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Sherbrooke, Quebec, J1G 5K2, Canada

Location

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Oulu, 90100, Finland

Location

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Seinäjoki, 60220, Finland

Location

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Dippoldiswalde, 01744, Germany

Location

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Dresden, 01307, Germany

Location

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Friedrichsthal, 66299, Germany

Location

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Furth im Wald, 93437, Germany

Location

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Goch, 47574, Germany

Location

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Hamburg, D-22587, Germany

Location

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Ludwigshafen, 67059, Germany

Location

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Münster, 48143, Germany

Location

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Saarbrücken, 66121, Germany

Location

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Schweinfurt, 97421, Germany

Location

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Sulzbach, 92237, Germany

Location

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Ampelokipoi, 11527, Greece

Location

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Athens, 11527, Greece

Location

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Thessaloniki, 56429, Greece

Location

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Budapest, H-1139, Hungary

Location

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Debrecen, 4032, Hungary

Location

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Makó, 6900, Hungary

Location

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Salgótarján, 3100, Hungary

Location

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Sopron, 9400, Hungary

Location

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Beersheba, 84350, Israel

Location

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Haifa, 35251, Israel

Location

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Raanana, 43452, Israel

Location

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Carpi, 41012, Italy

Location

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Castellanza, 21053, Italy

Location

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Foggia, 71100, Italy

Location

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Forlì, 47100, Italy

Location

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Rome, 00133, Italy

Location

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Sesto San Giovanni, 20099, Italy

Location

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Utena, 28151, Lithuania

Location

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Vilnius, LT-08661, Lithuania

Location

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Coatzacoalcos, 96400, Mexico

Location

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Mexico City, 11550, Mexico

Location

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Monterrey, 64620, Mexico

Location

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Auckland, 1640, New Zealand

Location

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Kamieniec Ząbkowicki, 57-230, Poland

Location

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Katowice, 40-772, Poland

Location

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Krakow, 31-455, Poland

Location

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Lodz, 93-338, Poland

Location

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Ruda Śląska, 41-709, Poland

Location

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Szczecin, 70-506, Poland

Location

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Tychy, 43-100, Poland

Location

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Warsaw, 01-192, Poland

Location

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Hato Rey, 00917, Puerto Rico

Location

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Manatí, 00674, Puerto Rico

Location

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San Juan, 00917-3104, Puerto Rico

Location

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Bucharest, 011234, Romania

Location

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Cluj-Napoca, 400006, Romania

Location

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Iași, 700547, Romania

Location

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Oradea, 410169, Romania

Location

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Ploieşti, 100342, Romania

Location

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Reşiţa, 320076, Romania

Location

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Târgu Mureş, 540098, Romania

Location

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Cheboksary, 428000, Russia

Location

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Kazan', 420012, Russia

Location

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Kursk, 303035, Russia

Location

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Novosibirsk, 630091, Russia

Location

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Saint Petersburg, 193257, Russia

Location

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Bratislava, 82102, Slovakia

Location

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Šaľa, 92701, Slovakia

Location

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Vranov nad Topľou, 09301, Slovakia

Location

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Paarl, 7646, South Africa

Location

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Parow, 7505, South Africa

Location

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Somerset West, 7130, South Africa

Location

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Alicante, 03114, Spain

Location

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Córdoba, 14004, Spain

Location

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Pozuelo de Alarcón, 28223, Spain

Location

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Requena, 46340, Spain

Location

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Seville, 41003, Spain

Location

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Toledo, 45004, Spain

Location

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Gaziantep, 27070, Turkey (Türkiye)

Location

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Hatay, 31040, Turkey (Türkiye)

Location

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Izmir, 35340, Turkey (Türkiye)

Location

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Kayseri, 38039, Turkey (Türkiye)

Location

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Mortimer, Berks, RG7 3SQ, United Kingdom

Location

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Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

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Guildford, Surrey, GU2 7XX, United Kingdom

Location

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Swansea, Wales, SA6 6NL, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 36542287DERIVED

  • 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.

    PMID: 29167192DERIVED

  • 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.

    PMID: 28587667DERIVED

  • 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.

    PMID: 28417532DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Insulin GlargineLY2605541

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800 545 5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 16, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 13, 2018

Results First Posted

April 13, 2018

Record last verified: 2018-03

Locations

CA(10)AU(4)LI(2)PR(3)NZ(1)SL(3)ZA(3)US(66)BR(4)RO(7)ES(6)GB(4)RU(5)ME(3)PL(8)AR(4)DE(11)TU(4)HU(5)IT(6)FI(2)GR(3)IL(3)