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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug); insulin lispro (Drug); Metformin (Drug); Insulin/ Glargine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Chief Medical Officer, MD, Study Director, Affiliation: Eli Lilly and Company

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30

Secondary outcome:

Percentage of Participants Achieving HbA1C < 7.0%

Percent of Participants Achieving HbA1c ≤ 6.5%.

Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.

Change in Total Cholesterol From Baseline to Week 30

Change in High Density Lipoprotein (HDL) From Baseline to Week 30

Change in Low Density Lipoprotein (LDL) From Baseline to Week 30

Change in Body Weight From Baseline to Week 30.

Change in Systolic Blood Pressure (SBP) From Baseline to Week 30

Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30

Daily Insulin Glargine Dose at Baseline and at Week 30

Major Hypoglycemia Rate Per Year

Minor Hypoglycemia Rate Per Year

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Research Site, Buenos Aires, Argentina

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

Starting date: September 2009
Last updated: March 19, 2015