Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00577824
First received: December 18, 2007
Last updated: June 6, 2014
Last verified: June 2014

December 18, 2007
June 6, 2014
January 2008
November 2008   (final data collection date for primary outcome measure)
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
To assess the hypothesis that glycemic control (mean change of HbA1c from baseline to endpoint) with exenatide is superior to placebo in Japanese patients with type 2 diabetes whose glycemic control is inadequate. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00577824 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Achieving HbA1c < 7.0% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)
  • Percentage of Patients Achieving HbA1c < 6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)
  • Change in Fasting Blood Glucose [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)
  • Change in Body Weight [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)
  • Change in Total Cholesterol [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
  • Change in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)
  • Change in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)
  • Change in Triglycerides [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)
  • Change in Waist Size [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)
  • Change in Waist-to-hip Ratio [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.
  • 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).
  • Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.
  • Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R) [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.
  • Change in Serum Insulin [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)
  • Change in C-peptide [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)
  • Change in 1,5-anhydroglucitol [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
    Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)
  • To assess the effect of exenatide on the following measures of efficacy: *Proportion of patients achieving HbA1c <7.0% and <6.5%; *Glucose (fasting); *Body weight; *Serum lipids; *Waist size and waist/hip ratio. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effect of exenatide on the following measures of efficacy: *Glucose measured at different times throughout the day; *Beta cell function and insulin sensitivity as assessed by homeostasis model assessment analyses and C-peptide. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effect of exenatide on the following measures of safety: *Treatment emergent adverse events; *Laboratory tests; *Vital signs; *Electrocardiogram; *Anti-exenatide antibody; *Hypoglycemia. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To measure the effect of exenatide on glycemic control (HbA1c) over an extended period of time. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)
Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: exenatide
    subcutaneous injection, 5mcg, twice a day
    Other Names:
    • LY2148568
    • Byetta
  • Drug: exenatide
    subcutaneous injection, 10mcg, twice a day
    Other Names:
    • LY2148568
    • Byetta
  • Drug: placebo
    subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day
  • Experimental: 1
    Intervention: Drug: exenatide
  • Experimental: 2
    Intervention: Drug: exenatide
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with type 2 diabetes.
  • Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
  • Have HbA1c 7.0% to 10% at study start.
  • Have a body weight >=50 kg.

Exclusion Criteria:

  • 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.
  • Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.
  • Have been treated with any exogenous insulin within 90 days before study start.
  • Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
  • The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00577824
H8O-JE-GWBB
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Chief Medical 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