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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00917267
First received: June 8, 2009
Last updated: June 13, 2014
Last verified: June 2014

June 8, 2009
June 13, 2014
July 2009
September 2010   (final data collection date for primary outcome measure)
Change in HbA1c From Baseline to Week 26. [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
Change in HbA1c from baseline to Week 26.
To estimate the difference in change in HbA1c from baseline to endpoint between 2 mg exenatide QW and 10 μg exenatide BID in patients with type 2 diabetes and inadequate glycemic control with OAD(s) alone or in combination [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00917267 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Achieving HbA1c Targets <=7% at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).
  • Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).
  • Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in FSG from baseline to Week 26.
  • Change in Body Weight (BW) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in BW from baseline to Week 26.
  • Change in Total Cholesterol (TC) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in TC from baseline to Week 26.
  • Change in High-Density Lipoprotein (HDL) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in HDL from baseline to Week 26.
  • Ratio of Triglycerides (TG) at Week 26 to Baseline [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    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.
  • Change in Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.
  • Assessment of Event Rate of Treatment-emergent Hypoglycemic Events [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: Yes ]
    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.
  • To compare exenatide QW and exenatide BID with respect to the proportion of patients achieving HbA1c ≤7% and ≤6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW and exenatide BID with respect to fasting serum glucose [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW and exenatide BID with respect to change in body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW & exenatide BID w/ respect to parameters related to glycemic control, including fasting & postprandial plasma glucose & 6-point SMBG profiles (blood glucose before & 2 hrs after the start of the morning, midday, & eve meals) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW and exenatide BID with respect to serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C] [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW and exenatide BID with respect to incidence and rate of hypoglycemic events [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW and exenatide BID with respect to safety, tolerability, and treatment-emergent events that could be related to immune phenomenon [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW and exenatide BID with respect to homeostasis model assessment of beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide once weekly
    2.0mg subcutaneous injection, once a week
  • Drug: exenatide twice daily
    5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
    Other Name: Byetta
  • Experimental: 1
    Intervention: Drug: exenatide once weekly
  • Active Comparator: 2
    Intervention: Drug: exenatide twice daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
691
April 2011
September 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   India,   Japan,   Korea, Republic of,   Taiwan
 
NCT00917267
H8O-MC-GWCK
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Chief Medical Officer Officer, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP