NCT01790438

Brief Summary

The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 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 night time blood sugar episodes
  • The total number of low blood sugar episodes reported

Trial Health

98
On Track

Trial Health Score

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

Enrollment
641

participants targeted

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

Timeline
Completed

Started Mar 2013

Geographic Reach
11 countries

63 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

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 3, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

February 11, 2013

Results QC Date

March 16, 2018

Last Update Submit

May 1, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

    Glycosylated hemoglobin A1 (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 by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.

    Baseline, 26 Weeks

Secondary Outcomes (22)

  • 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events

    Baseline through 26 Weeks

  • Percentage of Participants With HbA1c ≤6.5% and <7.0%

    26 Weeks

  • Fasting Serum Glucose (FSG) (by Laboratory)

    26 Weeks

  • Fasting Blood Glucose (FBG) (by Self Monitoring)

    26 Weeks

  • 6-Point Self-Monitored Blood Glucose (SMBG)

    26 Weeks

  • +17 more secondary outcomes

Study Arms (2)

LY2605541

EXPERIMENTAL

Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications \[OAM(s)\] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.

Drug: LY2605541Drug: Oral Antihyperglycemic Medications (OAM)

Human Insulin NPH

ACTIVE COMPARATOR

Administered by SC injection once daily at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.

Drug: Human Insulin NPHDrug: Oral Antihyperglycemic Medications (OAM)

Interventions

LY2605541DRUG
LY2605541
Human Insulin NPHDRUG
Human Insulin NPH
Oral Antihyperglycemic Medications (OAM)DRUG
Human Insulin NPHLY2605541

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, not treated with insulin
  • Have been receiving 2 or more OAMs for at least 3 months prior to the study
  • Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, 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 are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, 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 used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
  • Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before 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 before screening, prescription or over-the-counter medications to promote weight loss
  • Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma 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 or equal to 2 milligrams per deciliter (mg/dL) \[177 millimoles per liter (mmol/L)\]
  • Have obvious clinical signs or symptoms of liver disease \[excluding nonalcoholic fatty liver disease (NAFLD)\], acute or chronic hepatitis, nonalcoholic 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 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
  • Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (63)

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Tempe, Arizona, 85283, United States

Location

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Concord, California, 94520, United States

Location

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Fresno, California, 93720, United States

Location

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Lancaster, California, 93534, United States

Location

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Los Angeles, California, 90057, United States

Location

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Spring Valley, California, 91978, United States

Location

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Tustin, California, 92780, United States

Location

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Jacksonville, Florida, 32258, United States

Location

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Idaho Falls, Idaho, 83404, United States

Location

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Chicago, Illinois, 60640, United States

Location

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Des Moines, Iowa, 50314, United States

Location

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Topeka, Kansas, 66606, United States

Location

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Bloomfield Hills, Michigan, 48302, United States

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Nashua, New Hampshire, 03063, United States

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Greensboro, North Carolina, 27408, United States

Location

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Eugene, Oregon, 97401, United States

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Levittown, Pennsylvania, 19056, United States

Location

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Greer, South Carolina, 29651, United States

Location

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Knoxville, Tennessee, 37912, United States

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Spokane, Washington, 99202, United States

Location

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Buenos Aires, C1179AAB, Argentina

Location

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Caba, 2000, Argentina

Location

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Mar del Plata, B7600FZN, Argentina

Location

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Spruce Grove, Alberta, T7X 2V2, Canada

Location

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Burnaby, British Columbia, V5G 1T4, Canada

Location

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Kelowna, British Columbia, V1Y 1Z9, Canada

Location

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St. John's, Newfoundland and Labrador, A1E 2C2, Canada

Location

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Sherbrooke, Quebec, J1G 1B8, Canada

Location

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Brandýs nad Labem, 250 01, Czechia

Location

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Pardubice, 53002, Czechia

Location

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Plzen 2-Slovany, 32600, Czechia

Location

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Prague, 181 00, Czechia

Location

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Eisenach, 99817, Germany

Location

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Hohenmölsen, 06679, Germany

Location

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Münster, 48145, Germany

Location

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Saarbrücken, 66121, Germany

Location

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Saint Ingbert-Oberwürzbach, 66386, Germany

Location

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Schkeuditz, 04435, Germany

Location

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Budapest, 1171, Hungary

Location

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Gyöngyös, 3200, Hungary

Location

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Nagykanizsa, 8800, Hungary

Location

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Pápa, 8500, Hungary

Location

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Guadalajara, 44600, Mexico

Location

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Monterrey, 64460, Mexico

Location

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Gdynia, 81-557, Poland

Location

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Krakow, 30-015, Poland

Location

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Lodz, 90-242, Poland

Location

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Lublin, 20-538, Poland

Location

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Szczecin, 70-506, Poland

Location

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Las Lomas, 00921, Puerto Rico

Location

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Manatí, 00674, Puerto Rico

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San Juan, 00917-3104, Puerto Rico

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Yabucoa, 00767, Puerto Rico

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Bucheon-si, 420-717, South Korea

Location

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Daegu, 705-717, South Korea

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Goyang-si, 410-719, South Korea

Location

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Seoul, 110-744, South Korea

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Sungnam-Si, 463-712, South Korea

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Alzira, 46600, Spain

Location

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Barcelona, 08022, Spain

Location

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Málaga, 29010, Spain

Location

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Seville, 41003, Spain

Location

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Teruel, 44002, Spain

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

LY2605541Insulin, Isophane

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 9AM-5PM 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

February 11, 2013

First Posted

February 13, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 3, 2018

Results First Posted

May 3, 2018

Record last verified: 2018-05

Locations

HU(4)PL(5)ME(2)CZ(4)US(20)AR(3)PR(4)KR(5)DE(6)CA(5)ES(5)