NCT01468987

Brief Summary

The purpose of this study is:

  • To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
  • To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
  • To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
  • To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 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
1,369

participants targeted

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

Timeline
Completed

Started Dec 2011

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
24 countries

154 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

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

November 8, 2011

Results QC Date

March 16, 2018

Last Update Submit

March 16, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks

    HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and number of insulin injections at baseline \[1, 2, or ≥3\]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.

    Baseline, 26 weeks

Secondary Outcomes (19)

  • Total Hypoglycemia Rates (Adjusted for 30 Days)

    Baseline through 26 weeks

  • Percentage of Participants With Total Hypoglycemia Episodes

    Baseline through 26 weeks

  • Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)

    Baseline through 26 weeks

  • Percentage of Participants With Nocturnal Hypoglycemia Episodes

    Baseline through 26 weeks

  • Body Weight Change From Baseline to 26 Weeks

    Baseline, 26 weeks

  • +14 more secondary outcomes

Study Arms (2)

Insulin Glargine + Insulin Lispro

ACTIVE COMPARATOR

Participant-specific dose of Insulin Glargine will be administered subcutaneously (SC) once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro will be administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

Drug: Insulin GlargineDrug: Insulin Lispro

LY2605541 + Insulin Lispro

EXPERIMENTAL

Participant-specific dose of LY2605541 will be administered SC once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro will be administered SC for preprandial and supplemental doses for 26 weeks.

Drug: LY2605541Drug: Insulin Lispro

Interventions

LY2605541DRUG
Also known as: Insulin Peglispro
LY2605541 + Insulin Lispro
Insulin GlargineDRUG
Insulin Glargine + Insulin Lispro
Insulin LisproDRUG
Also known as: Humalog
Insulin Glargine + Insulin LisproLY2605541 + Insulin Lispro

Eligibility Criteria

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

You may qualify if:

  • Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification
  • Had diabetes ≥1 year
  • Have a hemoglobin A1c (HbA1c) value ≥7.0% and \<12.0% at screening
  • Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m\^2)
  • Participants on any glucose lowering regimen that contains at least 1 daily insulin injection
  • Are not breastfeeding
  • Test negative for pregnancy at screening and randomization
  • Do not intend to become pregnant during the study
  • Have practiced a reliable method of birth control for at least 6 weeks prior to screening
  • Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
  • Have access to a method of communication with the site
  • Have refrigeration in the home
  • Capable of, and willing to do the following: adhere to a multiple daily injection regimen, inject insulin with a covered vial and syringe and prefilled pen, attend some appointments in the fasting state, and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above
  • Have given written informed consent to participate in this study in accordance with local regulations

You may not qualify if:

  • Continuous subcutaneous insulin infusion therapy prior to screening
  • Are using twice daily insulin glargine prior to screening
  • Excessive insulin resistance defined as having received a daily dose of insulin ≥2.0 units per kilogram (units/kg) at the time of pre-randomization
  • Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening
  • Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening
  • Have fasting hypertriglyceridemia (defined as \>4.5 millimoles per liter \[mmol/L\], \>400 milligrams per deciliter \[mg/dL\]) at screening
  • Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
  • Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
  • Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
  • Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
  • Are currently receiving renal dialysis or have a serum creatinine ≥2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine
  • 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 as indicated below:
  • total bilirubin ≥2X the upper limit of normal (ULN) as defined by the central laboratory, or
  • alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \>2.5X ULN as defined by the central laboratory, or
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (156)

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Mobile, Alabama, 36617, United States

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Tucson, Arizona, 85724, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92801, United States

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Chino, California, 91710, United States

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Concord, California, 94520, United States

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Fresno, California, 93720, United States

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La Mesa, California, 91942, United States

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Lancaster, California, 93534, United States

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Mission Hills, California, 91345, United States

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Tustin, California, 92780, United States

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Longmont, Colorado, 80501, United States

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Daytona Beach, Florida, 32117, United States

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Jacksonville, Florida, 32204, United States

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West Palm Beach, Florida, 33401, United States

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Winter Haven, Florida, 33880, United States

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Atlanta, Georgia, 30308, United States

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Idaho Falls, Idaho, 83404, United States

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Springfield, Illinois, 62704, United States

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Des Moines, Iowa, 50314, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40503, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21204, United States

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Eagan, Minnesota, 55123, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59101, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89148, 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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New York, New York, 10025, United States

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Morehead City, North Carolina, 28557, United States

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Fargo, North Dakota, 58103, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Mentor, Ohio, 44060, United States

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Pittsburgh, Pennsylvania, 15224, United States

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Greer, South Carolina, 29651, United States

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Chattanooga, Tennessee, 37411, United States

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Memphis, Tennessee, 38119, United States

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Arlington, Texas, 76014, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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Renton, Washington, 98057, United States

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Spokane, Washington, 99202, United States

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Tacoma, Washington, 98405, United States

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Camperdown, New South Wales, 2050, Australia

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St Leonards, New South Wales, 2065, Australia

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Daw Park, South Australia, 5041, Australia

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East Ringwood, Victoria, 3135, Australia

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Geelong, Victoria, 3220, Australia

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Parkville, Victoria, 3050, Australia

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Fremantle, Western Australia, 6160, Australia

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Graz, 8036, Austria

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Vienna, A1090, Austria

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Aparecida de Goiânia, 74935530, Brazil

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Brasília, 71625-009, Brazil

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Čakovec, 40000, Croatia

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Osijek, 31000, Croatia

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Rijeka, HR-51000, Croatia

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Slavonski Brod, 35000, Croatia

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Varaždin, 42000, Croatia

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Zagreb, 10000, Croatia

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Holešov, 769 01, Czechia

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Hranice I-Mesto, 753 01, Czechia

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Krnov, 79401, Czechia

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Pardubice, 53002, Czechia

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Prague, 128 08, Czechia

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Copenhagen, 2400, Denmark

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Esbjerg, 6700, Denmark

Location

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Hillerød, 3400, Denmark

Location

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Berlin, 10409, Germany

Location

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Burghausen, 84489, Germany

Location

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Eisenach, 99817, Germany

Location

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Essen, 45355, Germany

Location

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Falkensee, 14612, Germany

Location

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Mainz, 55116, Germany

Location

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Mayen, 56727, Germany

Location

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Münster, 48153, Germany

Location

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Neuwied, 56564, Germany

Location

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Ampelokipoi, 11527, Greece

Location

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Athens, 11527, Greece

Location

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Nikaias - Piraeus, 18454, Greece

Location

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Thessaloniki, 54639, Greece

Location

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Békéscsaba, 5600, Hungary

Location

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Budapest, 1212, Hungary

Location

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Gyula, 5700, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Zalaegerszeg, 8900, Hungary

Location

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Beersheba, 84101, Israel

Location

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Holon, 58100, Israel

Location

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Jerusalem, 91120, Israel

Location

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Nahariya, 22100, Israel

Location

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Safed, 13110, Israel

Location

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Tel Litwinsky, 52621, Israel

Location

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Bergamo, 24128, Italy

Location

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Bologna, 40138, Italy

Location

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Olbia, 07026, Italy

Location

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Pavia, 27100, Italy

Location

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Rozzano, 20089, Italy

Location

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Kanagawa, 235-0045, Japan

Location

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Kumamoto, 862-0976, Japan

Location

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Tokyo, 1030002, Japan

Location

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Kaunas, LT-48259, Lithuania

Location

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Klaipėda, 92304, Lithuania

Location

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Monterrey, 64460, Mexico

Location

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Querétaro, 76000, Mexico

Location

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Tampico, 89000, Mexico

Location

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Dordrecht, 3317 NM, Netherlands

Location

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Groningen, 9728 NT, Netherlands

Location

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Heerlen, 6419 PC, Netherlands

Location

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Hoogeveen, 7909AA, Netherlands

Location

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Leiden, 2333 ZA, Netherlands

Location

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Krakow, 31-455, Poland

Location

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Lublin, 20-538, Poland

Location

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Sopot, 81-756, Poland

Location

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Szczecin, 70-506, Poland

Location

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Wroclaw, 50-306, Poland

Location

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Caguas, 00726, Puerto Rico

Location

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Las Lomas, 00921, 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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Yabucoa, 00767, Puerto Rico

Location

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Brasov, 500283, Romania

Location

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Cluj-Napoca, 400349, Romania

Location

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Oradea, 410169, Romania

Location

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Ploieşti, 100163, Romania

Location

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Satu Mare, 440055, Romania

Location

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Arkhangelsk, 163045, Russia

Location

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Moscow, 125367, Russia

Location

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Rostov-on-Don, 344022, Russia

Location

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Saint Petersburg, 198255, Russia

Location

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Dolný Kubín, 02601, Slovakia

Location

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Košice, 04012, Slovakia

Location

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Ľubochňa, 03491, Slovakia

Location

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Rožňava, 048 01, Slovakia

Location

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Barcelona, 08035, Spain

Location

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Málaga, 29010, Spain

Location

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Sabadell, 08208, Spain

Location

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Seville, 41003, Spain

Location

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Seville, 41010, Spain

Location

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Chiayi City, 600, Taiwan

Location

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Sindian City, 23148, Taiwan

Location

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Taichung, 404, Taiwan

Location

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Yong Kung City, 71004, Taiwan

Location

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Ankara, 06100, Turkey (Türkiye)

Location

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Diyarbakır, 21280, Turkey (Türkiye)

Location

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Istanbul, 34662, Turkey (Türkiye)

Location

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Kayseri, 38039, Turkey (Türkiye)

Location

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Kütahya, 43300, Turkey (Türkiye)

Location

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Middlesbrough, Cleveland, TS4 3BW, United Kingdom

Location

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Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

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Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

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Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2605541basal insulin peglisproInsulin GlargineInsulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

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 9 AM - 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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

December 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-03

Locations

DE(9)US(48)CR(6)GR(4)DK(3)HU(5)JP(3)ME(3)RU(4)TU(5)GB(4)IL(6)CZ(5)NL(5)BR(2)SL(4)AU(7)ES(5)TW(4)LI(2)IT(5)PR(5)RO(5)PL(5)