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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00917267
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : December 31, 2012
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: exenatide once weekly Drug: exenatide twice daily Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: exenatide once weekly
2.0mg subcutaneous injection, once a week
Active Comparator: 2 Drug: exenatide twice daily
5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
Other Name: Byetta


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c From Baseline to Week 26. [ Time Frame: Baseline, Week 26 ]
    Change in HbA1c from baseline to Week 26.


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917267


Locations
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China
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Chongqin, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
India
Research Site
Ahmedabad, India
Research Site
Aligarh, India
Research Site
Bangalore, India
Research Site
Ghaziabad, India
Research Site
Hyderabaad, India
Research Site
Indore, India
Research Site
Kolkata, India
Research Site
Mumbai, India
Research Site
Pune, India
Research Site
Trivandrum, India
Research Site
Uttar Pradesh, India
Research Site
Varanasi, India
Japan
Research Site
Ageo, Japan
Research Site
Chiyoda-ku, Japan
Research Site
Izumisano, Japan
Research Site
Kashiwara, Japan
Research Site
Kitaazumi-gun, Japan
Research Site
Kumamoto, Japan
Research Site
Kurume, Japan
Research Site
Matsumoto, Japan
Research Site
Matsuyama, Japan
Research Site
Miyazaki-shi, Japan
Research Site
Ooita-shi, Japan
Research Site
Osaka, Japan
Research Site
Ota-ku, Japan
Research Site
Shinjuku-ku, Japan
Research Site
Takatsuki, Japan
Research Site
Yokohama, Japan
Korea, Republic of
Research Site
Bucheon, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Taiwan
Research Site
Changhua, Taiwan
Research Site
Chia-Yi, Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan, Taiwan
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
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Study Director: Chief Medical Officer Officer, MD Eli Lilly and Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00917267    
Other Study ID Numbers: H8O-MC-GWCK
First Posted: June 10, 2009    Key Record Dates
Results First Posted: December 31, 2012
Last Update Posted: April 9, 2015
Last Verified: March 2015
Keywords provided by AstraZeneca:
diabetes
exenatide
once weekly
 Byetta
Amylin
Lilly
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists