NCT01454284

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 nocturnal 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 during 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
1,114

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
20 countries

119 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

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
4.2 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

2.1 years

First QC Date

October 14, 2011

Results QC Date

March 16, 2018

Last Update Submit

March 16, 2018

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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 treatment, stratification factors (country, baseline low density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter \[mmol/L\]) and ≥100 mg/dL (2.6 mmol/L)\], baseline prior basal insulin therapy \[insulin glargine/detemir/other\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.

    52 weeks

Secondary Outcomes (21)

  • Hemoglobin A1c (HbA1c)

    26 weeks

  • Change From Baseline to 52 Weeks in HbA1c

    Baseline, 52 weeks

  • Total Hypoglycemia Events

    Baseline through 26 weeks, Baseline through 52 weeks

  • Percentage of Participants With Total Hypoglycemic Events

    Baseline through 26 weeks, Baseline through 52 weeks

  • Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0%

    up to 26 weeks, up to 52 weeks

  • +16 more secondary outcomes

Study Arms (2)

LY2605541 + Insulin Lispro

EXPERIMENTAL

LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC) once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered SC at meal times for 52 weeks.

Drug: LY2605541Drug: Insulin Lispro

Glargine + Insulin Lispro

ACTIVE COMPARATOR

Glargine dose titrated based on blood glucose readings, administered SC once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered SC at meal times for 52 weeks.

Drug: GlargineDrug: Insulin Lispro

Interventions

GlargineDRUG
Glargine + Insulin Lispro
LY2605541DRUG
LY2605541 + Insulin Lispro
Insulin LisproDRUG
Also known as: LY275585, Humalog
Glargine + Insulin LisproLY2605541 + Insulin Lispro

Eligibility Criteria

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

You may qualify if:

  • Type 1 diabetes for at least 1 year
  • HbA1c value less than 12 percent according to the central laboratory at screening
  • Body mass index of less than or equal to 35.0 kilograms per square meter (kg/m\^2)
  • Have been treated for at least 90 days prior to screening with
  • insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH) in combination with pre-meal insulin, or
  • self-mixed or pre-mixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
  • continuous SC insulin infusion therapy
  • Women who are not breast feeding and test negative for pregnancy before receiving treatment and agree to use reliable birth control until 2 weeks after last treatment with study drug
  • Are capable and willing to adhere to multiple daily injections, inject with a vial and syringe and prefilled pen and perform self-monitored blood glucose (SMBG) readings and record keeping

You may not qualify if:

  • Are using twice daily insulin glargine having been inadequately controlled on single daily dose of glargine prior to screening
  • Excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (U/kg) at the time of randomization
  • Receiving any oral or injectable medication (other than insulins or metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus in the 90 days prior to screening
  • Lipid lowering medications:
  • are using niacin preparations as 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 or more prior to screening
  • Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter \[mmol/L\], greater than 400 milligrams per deciliter \[mg/dL\]) at screening, as determined by the central laboratory.
  • Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening
  • Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within 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 2.5 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 as indicated below:
  • total bilirubin 2 times or more than the upper limit of normal (ULN) as defined by the central laboratory, or
  • alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) more than 2.5 times ULN as defined by the central laboratory, or
  • aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT) more than 2.5 times ULN as defined by the central laboratory
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (119)

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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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Tustin, California, 92780, United States

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Aurora, Colorado, 80045, United States

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Longmont, Colorado, 80501, United States

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Bradenton, Florida, 34208, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32258, United States

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New Port Richey, Florida, 34652, United States

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West Palm Beach, Florida, 33401, United States

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Roswell, Georgia, 30076, 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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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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Wichita, Kansas, 67226, United States

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Lexington, Kentucky, 40503, United States

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Metairie, Louisiana, 70006, United States

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Baltimore, Maryland, 21204, United States

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Eagan, Minnesota, 55123, United States

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Minneapolis, Minnesota, 55416, United States

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Chesterfield, Missouri, 63017, United States

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Springfield, Missouri, 65807, 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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Albany, New York, 12208, United States

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Durham, North Carolina, 27713, United States

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Morehead City, North Carolina, 28557, United States

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Mentor, Ohio, 44060, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97210, 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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Chattanooga, Tennessee, 37411, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77095, United States

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Round Rock, Texas, 78681, United States

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Ogden, Utah, 84403, United States

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Federal Way, Washington, 98003, United States

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Spokane, Washington, 99202, United States

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Tacoma, Washington, 98405, United States

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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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Parkville, Victoria, 3050, Australia

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Brussels, 1070, Belgium

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Edegem, 2650, Belgium

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Huy, 4500, Belgium

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Sint-Niklaas, 9100, Belgium

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Fortaleza, 60430-350, Brazil

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Porto Alegre, 91350250, Brazil

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São Paulo, 01244-030, Brazil

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Edmonton, Alberta, T5J 3N4, Canada

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Red Deer, Alberta, T4N 6V7, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Osijek, 31000, Croatia

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Copenhagen, 2400, Denmark

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La Rochelle, 17019, France

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Le Creuzot, 71200, France

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Paris, 75022, France

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Rouen, 76031, France

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Athens, 10552, Greece

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Chalcis, 341 00, Greece

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Thessaloniki, 56429, Greece

Location

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Dublin, Ireland

Location

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Haifa, 31096, Israel

Location

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Jerusalem, 91120, Israel

Location

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Petah Tikva, 49100, Israel

Location

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Petah Tikva, 49451, Israel

Location

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Tel Litwinsky, 52621, Israel

Location

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Jonava, LT-55201, Lithuania

Location

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Kaunas, LT-51270, Lithuania

Location

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Dordrecht, 3317 NM, Netherlands

Location

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Groningen, 9728 NT, Netherlands

Location

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Christchurch, 8001, New Zealand

Location

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Wellington, 6021, New Zealand

Location

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Gdansk, 80-546, Poland

Location

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Katowice, 40-057, Poland

Location

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Krakow, 31-261, Poland

Location

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Lubin, 59-300, Poland

Location

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Lublin, 20-538, Poland

Location

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Szczecin, 70-506, Poland

Location

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Warsaw, 02-507, Poland

Location

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Štúrovo, 943 01, Slovakia

Location

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Houghton Estate, 2198, South Africa

Location

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Pretoria, 0002, South Africa

Location

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Somerset West, 7130, South Africa

Location

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Alcalá de Henares, 28805, Spain

Location

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Alzira, 46600, Spain

Location

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Barcelona, 08036, Spain

Location

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Málaga, 29006, Spain

Location

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Seville, 41003, Spain

Location

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Seville, 41014, Spain

Location

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Valencia, 46014, Spain

Location

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Alingsås, 44183, Sweden

Location

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Helsingborg, 25187, Sweden

Location

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Huddinge, 14186, Sweden

Location

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Karlstad, SE-651 85, Sweden

Location

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Bristol, Avon, BS10 5NB, United Kingdom

Location

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Portsmouth, Hampshire, P06 3LY, United Kingdom

Location

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Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

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Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

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Inverness, Scotland, IV2 3JH, United Kingdom

Location

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Ipswich, Suffolk, IP4 5PD, 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

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Glasgow, G21 3UW, United Kingdom

Location

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Northampton, NN1 5BD, United Kingdom

Location

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Oxford, OX3 7LJ, 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 1

Interventions

Insulin GlargineLY2605541Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-03

Locations

SL(1)SE(4)ES(7)LI(2)ZA(3)GB(11)IL(5)CA(7)US(47)CR(1)BE(4)DK(1)BR(3)GR(3)NL(2)NZ(2)PL(7)AU(4)FR(4)IE(1)