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
Overview[ - collapse ][ - ]
Purpose | The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: exenatide Drug: insulin lispro Drug: Metformin Drug: Insulin/ Glargine |
Phase | Phase 3 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00960661 |
First Received | August 17, 2009 |
Last Updated | November 21, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | August 17, 2009 |
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Last Updated Date | November 21, 2013 |
Start Date | September 2009 |
Estimated Primary Completion Date | August 2012 |
Current Primary Outcome Measures | Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 [Time Frame: Baseline, 30 weeks] [Designated as safety issue: No]Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline). |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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 |
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Official Title | A Randomized 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 Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea |
Brief Summary | The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: exenatide subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day Other Names: ByettaDrug: insulin lispro titrated based on pre-meal glucose level; three times a day Other Names: HumalogDrug: Metformin Drug: Insulin/ Glargine |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 1036 |
Estimated Completion Date | August 2012 |
Estimated Primary Completion Date | August 2012 |
Eligibility Criteria | Inclusion Criteria: - Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start. - 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: - Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label. - 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Argentina, Belgium, Estonia, Finland, France, Germany, Greece, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russian Federation, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00960661 |
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Other Study ID Numbers | H8O-EW-GWDM |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Eli Lilly and Company |
Investigators | Study Director: Chief Medical Officer, MD Eli Lilly and Company |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Research Site | Buenos Aires, Argentina |
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Research Site | Caba, Argentina |
Research Site | Capital Federal, Argentina |
Research Site | Ciudad Autonoma de Buenos Aire, Argentina |
Research Site | Ciudad de Buenos Aires, Argentina |
Research Site | Corrientes, Argentina |
Research Site | Rosario, Argentina |
Research Site | San Rafael, Argentina |
Research Site | Arlon, Belgium |
Research Site | Bonheiden, Belgium |
Research Site | Edegem, Belgium |
Research Site | Merksem, Belgium |
Research Site | Tallinn, Estonia |
Research Site | Tartu, Estonia |
Research Site | Helsinki, Finland |
Research Site | Oulu, Finland |
Research Site | Vantaa, Finland |
Research Site | Angers, France |
Research Site | Auxerre, France |
Research Site | Bar Le Duc, France |
Research Site | Douai Cedex, France |
Research Site | La Roche Sur Yon, France |
Research Site | La Rochelle Cedex 1, France |
Research Site | Le Creuzot, France |
Research Site | Lille Cedex, France |
Research Site | Marseille Cedex 20, France |
Research Site | Montpellier Cedex 5, France |
Research Site | Nanterre, France |
Research Site | Pessac Cedex, France |
Research Site | Rennes Cedex 2, France |
Research Site | Strasbourg, France |
Research Site | Toulouse Cedex 9, France |
Research Site | Venissieux, France |
Research Site | Bad Lauterberg, Germany |
Research Site | Dippoldiswalde, Germany |
Research Site | Friedrichsthal, Germany |
Research Site | Goch, Germany |
Research Site | Grevenbroich, Germany |
Research Site | Hamburg, Germany |
Research Site | Mainz, Germany |
Research Site | Saarbruecken, Germany |
Research Site | Athens, Greece |
Research Site | Thessaloniki, Greece |
Research Site | Firenze, Italy |
Research Site | Napoli, Italy |
Research Site | Olbia, Italy |
Research Site | Perugia, Italy |
Research Site | Trieste, Italy |
Research Site | Verona, Italy |
Research Site | Seoul, Korea, Republic of |
Research Site | Ulsan-Si, Korea, Republic of |
Research Site | Wonju-Si, Korea, Republic of |
Research Site | Aguascalientes, Mexico |
Research Site | Cuernavaca, Mexico |
Research Site | Mexico City, Mexico |
Research Site | Monterrey, Mexico |
Research Site | Almere, Netherlands |
Research Site | Amsterdam, Netherlands |
Research Site | Beek, Netherlands |
Research Site | Den Haag, Netherlands |
Research Site | Groningen, Netherlands |
Research Site | Heerlen, Netherlands |
Research Site | Hoogeveen, Netherlands |
Research Site | Sittard-Geleen, Netherlands |
Research Site | Coimbra, Portugal |
Research Site | Lisboa, Portugal |
Research Site | Lisbon, Portugal |
Research Site | Portugal, Portugal |
Research Site | Hato Rey, Puerto Rico |
Research Site | Bucharest, Romania |
Research Site | Bucuresti, Romania |
Research Site | Cluj-Napoca, Romania |
Research Site | Constanta, Romania |
Research Site | Craiova, Romania |
Research Site | Oradea, Romania |
Research Site | Ploiesti, Romania |
Research Site | Arkhangelsk, Russian Federation |
Research Site | Rostov-on-Don, Russian Federation |
Research Site | St. Petersburg, Russian Federation |
Research Site | Alicante, Spain |
Research Site | Barcelona, Spain |
Research Site | Dos Hermanas, Spain |
Research Site | La Coruna, Spain |
Research Site | Santander, Spain |
Research Site | Valencia, Spain |
Research Site | Halmstad, Sweden |
Research Site | Karlstad, Sweden |
Research Site | Lund, Sweden |
Research Site | Malmo, Sweden |
Research Site | Solna, Sweden |
Research Site | Stockholm, Sweden |
Research Site | Umea, 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 |