Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

March 20, 2015 updated by: AstraZeneca

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

820

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
      • Mar del Plata, Argentina
        • Research Site
  • Belgium
      • Leuven, Belgium
        • Research Site
      • Marchovelette, Belgium
        • Research Site
      • Tessenderlo, Belgium
        • Research Site
  • Brazil
      • Brasilia, Brazil
        • Research Site
      • Campinas, Brazil
        • Research Site
      • Curitiba, Brazil
        • Research Site
      • Fortaleza, Brazil
        • Research Site
      • Joinville, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Recife, Brazil
        • Research Site
      • Sao Paolo, Brazil
        • Research Site
  • Canada
      • Mississauga, Canada
        • Research Site
      • Petitcodiac, Canada
        • Research Site
      • Pointe-Claire, Canada
        • Research Site
      • Regina, Canada
        • Research Site
      • Saint John, Canada
        • Research Site
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • Research Site
      • Penticton, British Columbia, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
    • Quebec
      • Gatineu, Quebec, Canada
        • Research Site
  • France
      • Chateaugiron, France
        • Research Site
      • Murs Erigne, France
        • Research Site
      • Nantes, France
        • Research Site
      • Vieux Conde, France
        • Research Site
  • Germany
      • Dresden, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Muenster, Germany
        • Research Site
      • Rodgau, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Hodmezovasarhely, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
  • India
      • Ahmedabad, India
        • Research Site
      • Bangalore, India
        • Research Site
      • Channai, India
        • Research Site
      • Cochin, India
        • Research Site
      • Mumbai, India
        • Research Site
      • New Dehli, India
        • Research Site
      • Pune, India
        • Research Site
  • Israel
      • Holon, Israel
        • Research Site
      • Tel-Hashomer, Israel
        • Research Site
  • Italy
      • Firenze, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Siena, Italy
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Research Site
      • Daegu, Korea, Republic of
        • Research Site
      • Jeonju, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Sungnam, Korea, Republic of
        • Research Site
  • Mexico
      • Chihuahua, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
  • Poland
      • Lublin, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Puerto Rico
      • Manati, Puerto Rico
        • Research Site
      • Toa Baja, Puerto Rico
        • Research Site
  • Romania
      • Galati, Romania
        • Research Site
      • Oradea, Romania
        • Research Site
      • Targu Mures, Romania
        • Research Site
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Rostov-on-Don, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Stavropol, Russian Federation
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Trebisov, Slovakia
        • Research Site
  • South Africa
      • Johannesburg, South Africa
        • Research Site
      • Kempton Park, South Africa
        • Research Site
      • Midrand, South Africa
        • Research Site
      • Soweto, South Africa
        • Research Site
  • Spain
      • Alicante, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Sisli-Istanbul, Turkey
        • Research Site
  • United Kingdom
      • Bath, United Kingdom
        • Research Site
      • Birmingham, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Frome, United Kingdom
        • Research Site
      • Guildford, United Kingdom
        • Research Site
      • Hull, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Swansea, United Kingdom
        • Research Site
  • United States
    • California
      • Buena Park, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Valencia, California, United States
        • Research Site
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Idaho
      • Meridian, Idaho, United States
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States
        • Research Site
    • Michigan
      • Grand Rapids, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Montana
      • Billings, Montana, United States
        • Research Site
    • New Jersey
      • Toms River, New Jersey, United States
        • Research Site
    • North Carolina
      • Wilmington, North Carolina, United States
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Wilke Barre, Pennsylvania, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • El Paso, Texas, United States
        • Research Site
      • New Branufels, Texas, United States
        • 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 type 2 diabetes and are treated with diet and exercise alone.
  • at least 18 years of age.
  • HbA1c between 7.1% and 11.0%, inclusive.
  • Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
  • Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

  • Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
  • Have a history of renal transplantation or are currently receiving renal dialysis
  • Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
  • Have history of severe GI disorder (e.g., gastroparesis)
  • Have a history of acute or chronic pancreatitis.
  • Have active proliferative retinopathy.
  • Have been treated with drugs that promote weight loss (e.g., Xenical®[orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
  • Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
  • Have had an organ transplant.
  • Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Are currently enrolled in any other clinical study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sitagliptin
Drug: sitagliptin
oral, 100 mg, daily plus placebo once weekly subcutaneous injection
Active Comparator: Pioglitazone
Drug: pioglitazone
oral, 30-45mg, daily plus placebo once weekly subcutaneous injection
Active Comparator: Metformin
Drug: metformin
oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection
Experimental: Exenatide Once Weekly
Drug: exenatide once weekly
subcutaneous injection, 2mg, once weekly plus placebo oral once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in HbA1c from baseline to Week 26.
Baseline, Week 26
Percentage of Patients Achieving HbA1c <=7% at Week 26
Time Frame: Baseline, Week 26
Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with baseline HbA1c >7%).
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in FSG from baseline to Week 26.
Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in Body Weight from baseline to Week 26.
Baseline, Week 26
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in Fasting TC from baseline to Week 26.
Baseline, Week 26
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in Fasting HDL from baseline to Week 26.
Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time Frame: Baseline, Week 26
Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.
Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Time Frame: Baseline to Week 26
Major hypoglycemia is defined as any event that has 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]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).
Baseline to Week 26
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events
Time Frame: Baseline to Week 26
Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).
Baseline to Week 26
Change in Systolic Blood Pressure From Baseline to Week 26.
Time Frame: Baseline, Week 26
Change in Systolic Blood Pressure from baseline to Week 26.
Baseline, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26.
Time Frame: Baseline, Week 26
Change in Diastolic Blood Pressure from baseline to Week 26.
Baseline, Week 26

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

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWCH (DURATION - 4)

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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