The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
NCT ID: NCT00279201
Last Updated: 2011-02-21
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
2091 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-12-31
Study Completion Date
2009-11-30
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Insulin glargine
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.
Group Type
ACTIVE_COMPARATOR
Insulin glargine
Intervention Type
DRUG
Subcutaneous injection daily
Lispro Low Mix
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.
Group Type
EXPERIMENTAL
Lispro Low Mix
Intervention Type
DRUG
Subcutaneous injection twice daily.
Lispro Mid Mix prior Lispro Low Mix addendum
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.
Group Type
EXPERIMENTAL
Lispro Mid Mix
Intervention Type
DRUG
Lispro Mid Mix subcutaneous injection 3 times daily.
Lispro Low Mix prior Glargine addendum
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
Group Type
EXPERIMENTAL
Lispro Low Mix
Intervention Type
DRUG
Subcutaneous injection twice daily.
Basal bolus prior Lispro Low Mix addendum
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.
Group Type
ACTIVE_COMPARATOR
Insulin glargine
Intervention Type
DRUG
Subcutaneous injection daily
Lispro
Intervention Type
DRUG
Lispro subcutaneous injection 3 times daily.
Basal bolus prior Glargine addendum
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.
Group Type
ACTIVE_COMPARATOR
Insulin glargine
Intervention Type
DRUG
Subcutaneous injection daily
Lispro
Intervention Type
DRUG
Lispro subcutaneous injection 3 times daily.
Interventions
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Insulin glargine
Subcutaneous injection daily
Intervention Type
DRUG
Lispro Low Mix
Subcutaneous injection twice daily.
Intervention Type
DRUG
Lispro Mid Mix
Lispro Mid Mix subcutaneous injection 3 times daily.
Intervention Type
DRUG
Lispro
Lispro subcutaneous injection 3 times daily.
Intervention Type
DRUG
Other Intervention Names
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Lantus
Humalog Mix 75/25
Humalog Mix 50/50
Humalog
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
30 Years
Maximum Eligible Age
79 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Eli Lilly
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Troy, Michigan, United States
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Bloomington, Minnesota, United States
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Chesterfield, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Nashua, New Hampshire, United States
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Cherry Hill, New Jersey, United States
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Flemington, New Jersey, United States
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Hamilton, New Jersey, United States
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Stratford, New Jersey, United States
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Teaneck, New Jersey, United States
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Toms River, New Jersey, United States
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Cooperstown, New York, United States
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Mamaroneck, New York, United States
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Massapequa, New York, United States
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New Hartford, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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Westfield, New York, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Huntersville, North Carolina, United States
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Morehead City, North Carolina, United States
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Morganton, North Carolina, United States
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Tabor City, North Carolina, United States
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Fargo, North Dakota, United States
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Jamestown, North Dakota, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Franklin, Ohio, United States
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London, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Fleetwood, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Hartsville, South Carolina, United States
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Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Abilene, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Killeen, Texas, United States
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Midland, Texas, United States
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New Braunfels, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Provo, Utah, United States
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South Burlington, Vermont, United States
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Bellingham, Washington, United States
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Everett, Washington, United States
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Olympia, Washington, United States
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Renton, Washington, United States
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Wenatchee, Washington, United States
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Eau Claire, Wisconsin, United States
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Marshfield, Wisconsin, United States
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Buenos Aires, , Argentina
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Mar del Plata, , Argentina
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Pilar, , Argentina
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Kingswood Penrith, New South Wales, Australia
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Elizabeth Vale, South Australia, Australia
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Keswick, South Australia, Australia
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Burnie, Tasmania, Australia
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Box Hill, Victoria, Australia
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Nedlands, Western Australia, Australia
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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Setor Oeste/Goiania, , Brazil
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Calgary, Alberta, Canada
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Red Deer, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Petitcodiac, New Brunswick, Canada
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Ajax, Ontario, Canada
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Mississauga, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Laval, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Athens, , Greece
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Nikaias - Piraeus, , Greece
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Thessaloniki, , Greece
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Eger, , Hungary
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Pécs, , Hungary
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Szekszárd, , Hungary
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Szentes, , Hungary
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Ahemdabad, , India
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Aligarh, , India
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Bangalore, , India
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Coimbatore, , India
Site Status
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Hyderabaad, , India
Site Status
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Karnal/Haryana, , India
Site Status
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Trivandrum, , India
Site Status
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Amsterdam, , Netherlands
Site Status
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Brunssum, , Netherlands
Site Status
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Emmen, , Netherlands
Site Status
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Hoogeveen, , Netherlands
Site Status
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Nijmegen, , Netherlands
Site Status
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Venlo, , Netherlands
Site Status
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Zwijndrecht, , Netherlands
Site Status
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Bayamón, , Puerto Rico
Site Status
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Carolina, , Puerto Rico
Site Status
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Orcorvis, , Puerto Rico
Site Status
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Ponce, , Puerto Rico
Site Status
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Rio Piedras, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Brasov, , Romania
Site Status
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Bucharest, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Târgu Mureş, , Romania
Site Status
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Timișoara, , Romania
Site Status
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Alzira, , Spain
Site Status
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Dos Hermanas, , Spain
Site Status
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Madrid, , Spain
Site Status
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Málaga, , Spain
Site Status
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Mosteles, , Spain
Site Status
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Requena, , Spain
Site Status
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Santander, , Spain
Site Status
Countries
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United States
Argentina
Australia
Brazil
Canada
Greece
Hungary
India
Netherlands
Puerto Rico
Romania
Spain
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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F3Z-US-IOOV
Identifier Type: OTHER
Identifier Source: secondary_id
10455
Identifier Type: -
Identifier Source: org_study_id
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