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Completed

NCT Number: NCT00917267

A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

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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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have been diagnosed with type 2 diabetes.
  • Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
  • Have a body mass index (BMI) of >21 kg/m2 and <35 kg/m2, inclusive.
  • Have a history of stable body weight (not varying by >5% for at least 90 days prior to study start).
  • Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.

Exclusion criteria

  • Have any contraindication for the OAD(s) that they use.
  • Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
  • Have received chronic >14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
  • Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
  • Have been treated for >2 weeks with any of the following excluded medications within 90 days prior to study start:
  • Insulin
  • Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
  • Pramlintide acetate
  • Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
  • Have had prior exposure to exenatide
  • Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.
  • 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

2.0mg subcutaneous injection, once a week

exenatide twice daily

Drug

5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)

Other names: Byetta

Primary outcomes

  1. Change in HbA1c From Baseline to Week 26.

    Time frame: Baseline, Week 26

    Change in HbA1c from baseline to Week 26.

Secondary outcomes

  1. Percentage of Patients Achieving HbA1c Targets <=7% at Week 26

    Time frame: Baseline, Week 26

    Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).

  2. Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26

    Time frame: Baseline, Week 26

    Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).

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

    Time frame: Baseline, Week 26

    Change in FSG from baseline to Week 26.

  4. Change in Body Weight (BW) From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in BW from baseline to Week 26.

  5. Change in Total Cholesterol (TC) From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in TC from baseline to Week 26.

  6. Change in High-Density Lipoprotein (HDL) From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in HDL from baseline to Week 26.

  7. Ratio of Triglycerides (TG) at Week 26 to Baseline

    Time frame: Baseline, Week 26

    Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.

  8. Change in Blood Pressure From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.

  9. Assessment of Event Rate of Treatment-emergent Hypoglycemic Events

    Time frame: Baseline to Week 26

    Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any 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. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 10, 2009
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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