A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
NCT ID: NCT00960661
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1036 participants
INTERVENTIONAL
2009-09-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exenatide (BET)
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
exenatide
subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
Metformin
Insulin/ Glargine
Insulin Lispro (BBT)
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
insulin lispro
titrated based on pre-meal glucose level; three times a day
Metformin
Insulin/ Glargine
Interventions
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exenatide
subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
insulin lispro
titrated based on pre-meal glucose level; three times a day
Metformin
Insulin/ Glargine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
* Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
* Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
* Have an HbA1C \> 7.0% and ≤ 10.0%.
* Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.
Exclusion Criteria
* Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
* Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have previously completed or been withdrawn from this study after enrollment.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Buenos Aires, , Argentina
Research Site
Caba, , Argentina
Research Site
Capital Federal, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Corrientes, , Argentina
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Rosario, , Argentina
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San Rafael, , Argentina
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Arlon, , Belgium
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Bonheiden, , Belgium
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Edegem, , Belgium
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Merksem, , Belgium
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Tallinn, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Oulu, , Finland
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Vantaa, , Finland
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Angers, , France
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Auxerre, , France
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Bar-le-Duc, , France
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Douai, , France
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La Roche-sur-Yon, , France
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La Rochelle, , France
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Le Creuzot, , France
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Nanterre, , France
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Pessac, , France
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Rennes, , France
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Strasbourg, , France
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Toulouse, , France
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Vénissieux, , France
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Bad Lauterberg im Harz, , Germany
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Dippoldiswalde, , Germany
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Friedrichsthal, , Germany
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Goch, , Germany
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Grevenbroich, , Germany
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Hamburg, , Germany
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Mainz, , Germany
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Saarbrücken, , Germany
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Athens, , Greece
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Thessaloniki, , Greece
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Florence, , Italy
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Napoli, , Italy
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Olbia, , Italy
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Perugia, , Italy
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Trieste, , Italy
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Verona, , Italy
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Aguascalientes, , Mexico
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Cuernavaca, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Almere Stad, , Netherlands
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Amsterdam, , Netherlands
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Beek, , Netherlands
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Groningen, , Netherlands
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Heerlen, , Netherlands
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Hoogeveen, , Netherlands
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Sittard-Geleen, , Netherlands
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The Hague, , Netherlands
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Coimbra, , Portugal
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Lisbon, , Portugal
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Portugal, , Portugal
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Hato Rey, , Puerto Rico
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
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Craiova, , Romania
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Oradea, , Romania
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Ploieşti, , Romania
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Arkhangelsk, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Seoul, , South Korea
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Ulsan, , South Korea
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Wŏnju, , South Korea
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A Coruña, , Spain
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Alicante, , Spain
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Barcelona, , Spain
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Dos Hermanas, , Spain
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Santander, , Spain
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Valencia, , Spain
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Halmstad, , Sweden
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Karlstad, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Solna, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
Research Site
Bournemouth, , United Kingdom
Research Site
Ipswich, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Penarth, , United Kingdom
Research Site
Wakefield, , United Kingdom
Countries
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References
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Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.
Other Identifiers
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H8O-EW-GWDM
Identifier Type: -
Identifier Source: org_study_id
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