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OpenTrials
Completed

NCT Number: NCT00676338

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)

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide once weekly

Drug

subcutaneous injection, 2mg, once weekly plus placebo oral once daily

metformin

Drug

oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection

Sitagliptin

Drug

oral, 100 mg, daily plus placebo once weekly subcutaneous injection

pioglitazone

Drug

oral, 30-45mg, daily plus placebo once weekly subcutaneous injection

Primary outcomes

  1. Change in HbA1c From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in HbA1c from baseline to Week 26.

  2. 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%).

Secondary outcomes

  1. Change in Fasting Serum Glucose (FSG) From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in FSG from baseline to Week 26.

  2. Change in Body Weight From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in Body Weight from baseline to Week 26.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 13, 2008
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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