NCT00279201

Brief Summary

This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled. This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications. The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.

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
2,091

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
12 countries

199 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

Study Start

First participant enrolled

December 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 21, 2011

Completed
Last Updated

February 21, 2011

Status Verified

January 1, 2011

Enrollment Period

3.9 years

First QC Date

December 15, 2005

Results QC Date

November 11, 2010

Last Update Submit

January 24, 2011

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetestype 2

Outcome Measures

Primary Outcomes (3)

  • INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)

    Endpoint (Initiation: Week 24)

  • MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)

    HbA1c goal: HbA1c ≤7.0% or HbA1c \>7.0% but increased \<0.4% from last HbA1c ≤7.0%

    Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)

  • ADDENDUM: 24-Week Endpoint HbA1c

    HbA1c at 24-week endpoint in Intensification Addendum of the trial.

    Endpoint (Addendum) (24 weeks: Week 48)

Secondary Outcomes (53)

  • INITIATION: Change in HbA1c From Baseline to 24 Weeks

    Baseline (Initiation) to Endpoint (LOCF, Week 24)

  • INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint

    Endpoint (Initiation: Week 24)

  • INITIATION: HbA1c

    Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)

  • INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions

    Endpoint (LOCF) (Initiation: Week 24)

  • INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)

    Baseline (Initiation), Endpoint (Week 24)

  • +48 more secondary outcomes

Study Arms (6)

Insulin glargine

ACTIVE COMPARATOR

Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.

Drug: Insulin glargine

Lispro Low Mix

EXPERIMENTAL

Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.

Drug: Lispro Low Mix

Lispro Mid Mix prior Lispro Low Mix addendum

EXPERIMENTAL

Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.

Drug: Lispro Mid Mix

Lispro Low Mix prior Glargine addendum

EXPERIMENTAL

Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase

Drug: Lispro Low Mix

Basal bolus prior Lispro Low Mix addendum

ACTIVE COMPARATOR

Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.

Drug: Insulin glargineDrug: Lispro

Basal bolus prior Glargine addendum

ACTIVE COMPARATOR

Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.

Drug: Insulin glargineDrug: Lispro

Interventions

Insulin glargineDRUG

Subcutaneous injection daily

Also known as: Lantus
Basal bolus prior Glargine addendumBasal bolus prior Lispro Low Mix addendumInsulin glargine
Lispro Low MixDRUG

Subcutaneous injection twice daily.

Also known as: Humalog Mix 75/25
Lispro Low MixLispro Low Mix prior Glargine addendum
Lispro Mid MixDRUG

Lispro Mid Mix subcutaneous injection 3 times daily.

Also known as: Humalog Mix 50/50
Lispro Mid Mix prior Lispro Low Mix addendum
LisproDRUG

Lispro subcutaneous injection 3 times daily.

Also known as: Humalog
Basal bolus prior Glargine addendumBasal bolus prior Lispro Low Mix addendum

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have type 2 diabetes.
  • Must be at least 30 and less than 80 years of age at the time of Visit 1.
  • Must be on at least two oral antidiabetes medications for at least 90 days.
  • Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

You may not qualify if:

  • Must not have used insulin on a regular basis in the last 12 months.
  • Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
  • Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
  • Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
  • Must not be pregnant or intend to get pregnant during course of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (199)

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Mobile, Alabama, 36617, United States

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Litchfield Park, Arizona, 85340, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92805, United States

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Beverly Hills, California, 90211, United States

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Burlingame, California, 94010, United States

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Concord, California, 94520, United States

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Fountain Valley, California, 92708, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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La Jolla, California, 92093, United States

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La Mesa, California, 91942, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90095, United States

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Los Gatos, California, 95032, United States

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Norwalk, California, 90650, United States

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Orange, California, 92868, United States

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Palm Springs, California, 92262, United States

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Sacramento, California, 95825, United States

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Salinas, California, 93901, United States

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San Diego, California, 92161, United States

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Spring Valley, California, 91978, United States

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Vacaville, California, 95687, United States

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Ventura, California, 93003, United States

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Colorado Springs, Colorado, 80917, United States

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Cromwell, Connecticut, 06416, United States

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Trumbull, Connecticut, 06611, United States

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Waterbury, Connecticut, 06708, United States

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Deerfield Beach, Florida, 33441, United States

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Gainesville, Florida, 32605, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32208, United States

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Kissimmee, Florida, 34741, United States

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Lake Worth, Florida, 33461, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33125, United States

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New Port Richey, Florida, 34655, United States

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Ocala, Florida, 34471, United States

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Tampa, Florida, 33603, United States

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West Palm Beach, Florida, 33401, United States

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Winter Park, Florida, 32789, United States

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Athens, Georgia, 30606, United States

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Atlanta, Georgia, 30342, United States

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Honolulu, Hawaii, 96814, United States

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Kellogg, Idaho, 83837, United States

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Belleville, Illinois, 62220, United States

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Chicago, Illinois, 60612, United States

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Gurnee, Illinois, 60031, United States

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O'Fallon, Illinois, 62269, United States

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Peoria, Illinois, 61615, United States

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Fort Wayne, Indiana, 46804, United States

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Indianapolis, Indiana, 46256, United States

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Waterloo, Iowa, 50702, United States

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Topeka, Kansas, 66606, United States

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Bowling Green, Kentucky, 42101, United States

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Madisonville, Kentucky, 42431, United States

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Owensboro, Kentucky, 42303, United States

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Baton Rouge, Louisiana, 70808, United States

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Metairie, Louisiana, 70006, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21204, United States

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Elkridge, Maryland, 21075, United States

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Elkton, Maryland, 21921, United States

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Reisterstown, Maryland, 21136, United States

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Rockville, Maryland, 20852, United States

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Towson, Maryland, 21204, United States

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Haverhill, Massachusetts, 01830, United States

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Waltham, Massachusetts, 02453, United States

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Worcester, Massachusetts, 01605, United States

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Bloomfield Hills, Michigan, 48302, United States

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Troy, Michigan, 48098, United States

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Bloomington, Minnesota, 55420, United States

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Chesterfield, Missouri, 63017, United States

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Las Vegas, Nevada, 89148, United States

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Reno, Nevada, 89509, United States

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Westfield, New York, 14787, United States

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Morehead City, North Carolina, 28557, United States

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Morganton, North Carolina, 28655, United States

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Tabor City, North Carolina, 28463, United States

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Fargo, North Dakota, 58104, United States

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Jamestown, North Dakota, 58401, United States

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Akron, Ohio, 44313, United States

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Cincinnati, Ohio, 45224, United States

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Columbus, Ohio, 43201, United States

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Dayton, Ohio, 45439, United States

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Franklin, Ohio, 45005, United States

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London, Ohio, 43140, United States

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Bend, Oregon, 97708, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97210, United States

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Beaver, Pennsylvania, 15009, United States

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Fleetwood, Pennsylvania, 19522, United States

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Levittown, Pennsylvania, 19056, United States

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Philadelphia, Pennsylvania, 19146, United States

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Charleston, South Carolina, 29412, United States

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Greenville, South Carolina, 29605, United States

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Hartsville, South Carolina, 29550, United States

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Johnson City, Tennessee, 37604, United States

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Kingsport, Tennessee, 37660, United States

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Memphis, Tennessee, 38119, United States

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Abilene, Texas, 79601, United States

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Dallas, Texas, 75246, United States

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El Paso, Texas, 79935, United States

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Houston, Texas, 77005, United States

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Killeen, Texas, 76543, United States

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Midland, Texas, 79705, United States

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New Braunfels, Texas, 78130, United States

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San Antonio, Texas, 78229, United States

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Ogden, Utah, 84403, United States

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Provo, Utah, 84604, United States

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South Burlington, Vermont, 05403, United States

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Bellingham, Washington, 98226, United States

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Everett, Washington, 98208, United States

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Olympia, Washington, 98502, United States

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Renton, Washington, 98057, United States

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Wenatchee, Washington, 98801, United States

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Eau Claire, Wisconsin, 54701, United States

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Marshfield, Wisconsin, 54449, United States

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Buenos Aires, C1188AAF, Argentina

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Mar del Plata, 7600, Argentina

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Pilar, B1629ODT, Argentina

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Kingswood Penrith, New South Wales, 2747, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Keswick, South Australia, 5035, Australia

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Burnie, Tasmania, 7320, Australia

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Nedlands, Western Australia, 6009, Australia

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Curitiba, 80060-900, Brazil

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Porto Alegre, 90035170, Brazil

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São Paulo, 01221-020, Brazil

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Setor Oeste/Goiania, 74043-110, Brazil

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Calgary, Alberta, T3B 0M3, Canada

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Red Deer, Alberta, T4N 6V7, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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Petitcodiac, New Brunswick, E4Z 4R6, Canada

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Ajax, Ontario, L1S 7K8, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Niagara Falls, Ontario, L2G 5X7, Canada

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Laval, Quebec, H7T 2P5, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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Athens, 11526, Greece

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Nikaias - Piraeus, 18454, Greece

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Thessaloniki, 56429, Greece

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Eger, 3300, Hungary

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Pécs, 7623, Hungary

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Szekszárd, 7100, Hungary

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Szentes, 6600, Hungary

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Ahemdabad, 380013, India

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Aligarh, 202002, India

Location

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Bangalore, 560 054, India

Location

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Coimbatore, India

Location

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Hyderabaad, 500033, India

Location

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Karnal/Haryana, 132 001, India

Location

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Trivandrum, 695029, India

Location

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Amsterdam, 1105 AZ, Netherlands

Location

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Brunssum, 6442 BE, Netherlands

Location

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Emmen, 7824 AA, Netherlands

Location

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Hoogeveen, 7909 AA, Netherlands

Location

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Nijmegen, 6500 HB, Netherlands

Location

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Venlo, 5912 BL, Netherlands

Location

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Zwijndrecht, 3331 LZ, Netherlands

Location

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Bayamón, 00959, Puerto Rico

Location

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Carolina, 00983, Puerto Rico

Location

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Orcorvis, 00720, Puerto Rico

Location

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Ponce, 00717-2075, Puerto Rico

Location

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Rio Piedras, 00936, Puerto Rico

Location

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San Juan, 00926, Puerto Rico

Location

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Brasov, 500326, Romania

Location

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Bucharest, 70266, Romania

Location

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Cluj-Napoca, 3400, Romania

Location

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Târgu Mureş, 540136, Romania

Location

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Timișoara, 1900, Romania

Location

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Alzira, 46600, Spain

Location

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Dos Hermanas, 41014, Spain

Location

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Madrid, 28040, Spain

Location

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Málaga, 29010, Spain

Location

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Mosteles, 28935, Spain

Location

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Requena, 46340, Spain

Location

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Santander, 39008, Spain

Location

Related Publications (10)

  • Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94(5):1689-94. doi: 10.1210/jc.2008-1940. Epub 2009 Mar 10.

    PMID: 19276235RESULT

  • Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sci Technol. 2008 Sep;2(5):831-8. doi: 10.1177/193229680800200514.

    PMID: 19885269RESULT

  • Scheen AJ, Schmitt H, Jiang HH, Ivanyi T. Individualizing treatment of type 2 diabetes by targeting postprandial or fasting hyperglycaemia: Response to a basal vs a premixed insulin regimen by HbA1c quartiles and ethnicity. Diabetes Metab. 2015 Jun;41(3):216-22. doi: 10.1016/j.diabet.2015.03.002. Epub 2015 Apr 14.

    PMID: 25881510DERIVED

  • Jovanovic L, Peters AL, Jiang HH, Hardin DS. Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes. Aging Clin Exp Res. 2014 Apr;26(2):115-21. doi: 10.1007/s40520-013-0140-8. Epub 2013 Oct 3.

    PMID: 24092662DERIVED

  • Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11.

    PMID: 23757434DERIVED

  • 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

  • Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL. The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011 Feb;34(2):249-55. doi: 10.2337/dc10-1701.

    PMID: 21270182DERIVED

  • Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther. 2010 May;32(5):896-908. doi: 10.1016/j.clinthera.2010.05.001.

    PMID: 20685497DERIVED

  • Wolffenbuttel BH, Klaff LJ, Bhushan R, Fahrbach JL, Jiang H, Martin S. Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose-lowering agents. Diabet Med. 2009 Nov;26(11):1147-55. doi: 10.1111/j.1464-5491.2009.02824.x.

    PMID: 19929994DERIVED

  • Buse JB, Wolffenbuttel BH, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL, Scism-Bacon JL, Martin SA. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1007-13. doi: 10.2337/dc08-2117. Epub 2009 Mar 31.

    PMID: 19336625DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Insulin Glargineinsulin lispro, isophane insulin lispro drug combination (25:75)Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose 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 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 15, 2005

First Posted

January 19, 2006

Study Start

December 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 21, 2011

Results First Posted

February 21, 2011

Record last verified: 2011-01

Locations

ES(7)AR(3)CA(9)NL(7)IN(7)HU(4)GR(3)BR(4)US(138)AU(6)RO(5)PR(6)