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

March 19, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1036

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • 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
  • Belgium
      • Arlon, Belgium
        • Research Site
      • Bonheiden, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Merksem, Belgium
        • Research Site
  • Estonia
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Vantaa, Finland
        • Research Site
  • France
      • 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
  • Germany
      • 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
  • Greece
      • Athens, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Italy
      • Firenze, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Olbia, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Trieste, Italy
        • Research Site
      • Verona, Italy
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
      • Ulsan-Si, Korea, Republic of
        • Research Site
      • Wonju-Si, Korea, Republic of
        • Research Site
  • Mexico
      • Aguascalientes, Mexico
        • Research Site
      • Cuernavaca, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
  • Netherlands
      • 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
  • Portugal
      • Coimbra, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Lisbon, Portugal
        • Research Site
      • Portugal, Portugal
        • Research Site
  • Puerto Rico
      • Hato Rey, Puerto Rico
        • Research Site
  • Romania
      • 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
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Research Site
      • Rostov-on-Don, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Spain
      • 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
  • Sweden
      • 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
  • United Kingdom
      • Bournemouth, United Kingdom
        • Research Site
      • Ipswich, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Penarth, United Kingdom
        • Research Site
      • Wakefield, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exenatide (BET)
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
Drug: Metformin
Drug: exenatide
subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
Other Names:
  • Byetta
Drug: Insulin/ Glargine
Active Comparator: Insulin Lispro (BBT)
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
Drug: Metformin
Drug: Insulin/ Glargine
Drug: insulin lispro
titrated based on pre-meal glucose level; three times a day
Other Names:
  • Humalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
Time Frame: Baseline, 30 weeks
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).
Baseline, 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving HbA1C < 7.0%
Time Frame: Week 30
Percentage of participants achieving HbA1C < 7.0%
Week 30
Percent of Participants Achieving HbA1c ≤ 6.5%.
Time Frame: Week 30
Percent of participants achieving HbA1c ≤ 6.5%.
Week 30
Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.
Time Frame: Baseline, Week 30
Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Baseline, Week 30
Change in Total Cholesterol From Baseline to Week 30
Time Frame: Baseline, week 30
Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Baseline, week 30
Change in High Density Lipoprotein (HDL) From Baseline to Week 30
Time Frame: Baseline, week 30
Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Baseline, week 30
Change in Low Density Lipoprotein (LDL) From Baseline to Week 30
Time Frame: Baseline, Week 30
Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Baseline, Week 30
Change in Body Weight From Baseline to Week 30.
Time Frame: baseline, week 30
Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
baseline, week 30
Change in Systolic Blood Pressure (SBP) From Baseline to Week 30
Time Frame: Baseline, Week 30
Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Baseline, Week 30
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30
Time Frame: baseline, Week 30
Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
baseline, Week 30
Daily Insulin Glargine Dose at Baseline and at Week 30
Time Frame: Baseline, week 30
Daily Insulin Glargine Dose at baseline and at Week 30
Baseline, week 30
Major Hypoglycemia Rate Per Year
Time Frame: 30 weeks
Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.
30 weeks
Minor Hypoglycemia Rate Per Year
Time Frame: 30 weeks
Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL)
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-EW-GWDM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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