NCT00494013

Brief Summary

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
442

participants targeted

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

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
9 countries

56 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

June 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 4, 2009

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

Enrollment Period

1.1 years

First QC Date

June 27, 2007

Results QC Date

September 25, 2009

Last Update Submit

November 4, 2009

Conditions

Diabetes Mellitus Type 2

Keywords

diabetestype 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)

    Baseline, 24 Weeks

Secondary Outcomes (11)

  • Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks

    Baseline, 12 Weeks, 24 Weeks

  • Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint

    24 Weeks

  • Glycemic Variability

    24 Weeks

  • 7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint

    24 Weeks

  • Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods

    Baseline to 24 Weeks

  • +6 more secondary outcomes

Study Arms (2)

Insulin Lispro Protamine Suspension

EXPERIMENTAL

Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.

Drug: Insulin Lispro Protamine Suspension

Detemir

ACTIVE COMPARATOR

Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

Drug: Detemir

Interventions

Insulin Lispro Protamine SuspensionDRUG

Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.

Also known as: Neutral Protamine Lispro (NPL), Humalog, ILPS
Insulin Lispro Protamine Suspension
DetemirDRUG

Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

Detemir

Eligibility Criteria

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

You may qualify if:

  • Have type 2 diabetes mellitus for at least 1 year.
  • Are at least 18 years old.
  • Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
  • Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
  • Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

You may not qualify if:

  • Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
  • Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
  • Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter \[micromol/L\]).
  • Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase \[ALT\], or aspartate transaminase \[AST\] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (56)

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.

Hueytown, Alabama, 35023, United States

Location

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Litchfield Park, Arizona, 85340, United States

Location

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Phoenix, Arizona, 85016, United States

Location

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Buena Park, California, 90620, United States

Location

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Fountain Valley, California, 92708, United States

Location

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Los Angeles, California, 90057, United States

Location

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Jacksonville, Florida, 32257, United States

Location

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Atlanta, Georgia, 30312, United States

Location

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Chicago, Illinois, 60612, United States

Location

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Evansville, Indiana, 47714, United States

Location

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Indianapolis, Indiana, 46202, United States

Location

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Newburgh, Indiana, 47630, United States

Location

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Lexington, Kentucky, 40503, United States

Location

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Slidell, Louisiana, 70458, United States

Location

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Prince Frederick, Maryland, 20678, United States

Location

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Novi, Michigan, 48374, United States

Location

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Las Vegas, Nevada, 89101, United States

Location

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Syracuse, New York, 13210, United States

Location

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Goldsboro, North Carolina, 27530, United States

Location

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Cincinnati, Ohio, 45236, United States

Location

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London, Ohio, 43140, United States

Location

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Bend, Oregon, 97701, United States

Location

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Lansdale, Pennsylvania, 19446, United States

Location

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Taylors, South Carolina, 29687, United States

Location

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Johnson City, Tennessee, 37604, United States

Location

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Grand Prairie, Texas, 75052, United States

Location

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Menomonee Falls, Wisconsin, 53051, United States

Location

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Buenos Aires, C1188AAF, Argentina

Location

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Ramos Mejía, B1704ETD, Argentina

Location

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Budapest, H-1139, Hungary

Location

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Eger, 3300, Hungary

Location

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Makó, 6900, Hungary

Location

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Szekszárd, 7100, Hungary

Location

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Székesfehérvár, 8000, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Bangalore, 560052, India

Location

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Chennai, 600086, India

Location

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Kochi, 682026, India

Location

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Mumbai, 400 067, India

Location

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Pune, 411011, India

Location

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Chihuahua City, 31238, Mexico

Location

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Guadalajara, 44340, Mexico

Location

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Krakow, 30-349, Poland

Location

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Poznan, 61-495, Poland

Location

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Rzeszów, 35-068, Poland

Location

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Goyang-si, 410-719, South Korea

Location

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Sungnam-Si, 463-712, South Korea

Location

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Lugo, 27004, Spain

Location

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Palma de Mallorca, 07014, Spain

Location

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Santa Cruz de Tenerife, 38320, Spain

Location

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Valencia, 46015, Spain

Location

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Chiayi City, 600, Taiwan

Location

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Neihu Taipei, 114, Taiwan

Location

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Tainan, 704, Taiwan

Location

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Taipei, 100, Taiwan

Location

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Yung-Kang, Tainan, 710, Taiwan

Location

Related Publications (2)

  • Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.

    PMID: 23101951DERIVED

  • Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.

    PMID: 20546262DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

neutral protamine lispro insulinInsulin LisproInsulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 29, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 11, 2009

Results First Posted

November 4, 2009

Record last verified: 2009-11

Locations

ME(2)ES(4)HU(6)KR(2)IN(5)AR(2)TW(5)US(27)PL(3)