NCT01582451

Brief Summary

The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:

  • Change in participants' overall blood sugar control
  • The rate of night time low blood sugar episodes
  • The number of participants that reach blood sugar targets without low blood sugar episodes at night
  • The rate of low blood sugar episodes reported over a 24-hour period

Trial Health

93
On Track

Trial Health Score

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

Enrollment
466

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started May 2012

Geographic Reach
9 countries

61 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

April 19, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

April 20, 2018

Completed
Last Updated

April 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

April 19, 2012

Results QC Date

March 17, 2018

Last Update Submit

March 17, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)

    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, baseline low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.

    Baseline, 26 weeks

Secondary Outcomes (18)

  • Change From Baseline to 52 Weeks in HbA1c

    Baseline, 52 weeks

  • Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)

    Baseline through 26 weeks and Baseline through 52 weeks

  • Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events

    Baseline through 26 weeks and Baseline through 52 weeks

  • Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%

    26 and 52 weeks

  • Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia

    26 and 52 weeks

  • +13 more secondary outcomes

Study Arms (2)

LY2605541

EXPERIMENTAL

Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.

Drug: LY2605541

Insulin glargine

ACTIVE COMPARATOR

Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.

Drug: Insulin glargine

Interventions

LY2605541DRUG
Also known as: Insulin peglispro
LY2605541
Insulin glargineDRUG
Insulin glargine

Eligibility Criteria

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

You may qualify if:

  • Have had type 2 diabetes mellitus for at least 1 year
  • Have been receiving basal insulin (neutral protamine Hagedorn \[NPH\], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
  • Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
  • Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\^2)
  • Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug

You may not qualify if:

  • Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
  • Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
  • For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
  • Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter 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 diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV
  • Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter \[µmol/L\])
  • 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
  • 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 cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
  • Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter \[mmol/L\]) at screening
  • Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
  • Lipid-lowering medication: Are using or have used any of the following:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (61)

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.

Mesa, Arizona, 85213, United States

Location

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Phoenix, Arizona, 85050, United States

Location

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Concord, California, 94520, United States

Location

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Escondido, California, 92026, United States

Location

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Fresno, California, 93720, United States

Location

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Spring Valley, California, 91978, United States

Location

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Fort Lauderdale, Florida, 33316, United States

Location

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Miami, Florida, 33175, United States

Location

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New Port Richey, Florida, 34652, United States

Location

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Oviedo, Florida, 32765, United States

Location

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Roswell, Georgia, 30076, United States

Location

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Chicago, Illinois, 60607, United States

Location

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Crystal Lake, Illinois, 60012, United States

Location

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Bloomington, Indiana, 47402, United States

Location

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Topeka, Kansas, 66606, United States

Location

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Bangor, Maine, 04401, United States

Location

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Rockville, Maryland, 20852, United States

Location

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Springfield, Missouri, 65807, United States

Location

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Nashua, New Hampshire, 03063, United States

Location

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Toms River, New Jersey, 08753, United States

Location

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Durham, North Carolina, 27713, United States

Location

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Raleigh, North Carolina, 27609, United States

Location

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Akron, Ohio, 44304, United States

Location

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Delaware, Ohio, 43015, United States

Location

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Jackson, Tennessee, 38305, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Austin, Texas, 78731, United States

Location

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Dallas, Texas, 75251, United States

Location

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Round Rock, Texas, 78681, United States

Location

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Bountiful, Utah, 84010, United States

Location

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Federal Way, Washington, 98003, United States

Location

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Olympia, Washington, 98502, United States

Location

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Milwaukee, Wisconsin, 53226, United States

Location

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Beroun, 26601, Czechia

Location

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Brandýs nad Labem, 250 01, Czechia

Location

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Prague, 181 00, Czechia

Location

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Aschaffenburg, 63739, Germany

Location

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Bad Mergentheim, 97980, Germany

Location

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Damme, 49401, Germany

Location

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Dresden, 01307, Germany

Location

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Rhaunen, 55624, Germany

Location

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Chalcis, 341 00, Greece

Location

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Thessaloniki, 54639, Greece

Location

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Acre, 18274, Israel

Location

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Beersheba, 84350, Israel

Location

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Holon, 58100, Israel

Location

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Nazareth, 16000, Israel

Location

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Raanana, 43452, Israel

Location

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Bayamón, 00961, Puerto Rico

Location

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Ponce, 00717, Puerto Rico

Location

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Bucharest, 020359, Romania

Location

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Oradea, 410169, Romania

Location

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Sibiu, 550245, Romania

Location

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Arkhangelsk, 163045, Russia

Location

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Novosibirsk, 630091, Russia

Location

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Saint Petersburg, 192012, Russia

Location

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Alzira, 46600, Spain

Location

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Cadiz, 11540, Spain

Location

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Palma de Mallorca, 07010, Spain

Location

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Pozuelo de Alarcón, 28223, Spain

Location

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Teruel, 44001, Spain

Location

Related Publications (5)

  • 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

  • Buse JB, Rodbard HW, Trescoli Serrano C, Luo J, Ivanyi T, Bue-Valleskey J, Hartman ML, Carey MA, Chang AM; IMAGINE 5 Investigators. Randomized Clinical Trial Comparing Basal Insulin Peglispro and Insulin Glargine in Patients With Type 2 Diabetes Previously Treated With Basal Insulin: IMAGINE 5. Diabetes Care. 2016 Jan;39(1):92-100. doi: 10.2337/dc15-1531. Epub 2015 Nov 17.

    PMID: 26577417DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2605541basal insulin peglisproInsulin Glargine

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 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 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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 20, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

April 20, 2018

Results First Posted

April 20, 2018

Record last verified: 2018-03

Locations

ES(5)US(33)GR(2)PR(2)RU(3)RO(3)DE(5)CZ(3)IL(5)