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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: exenatide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 181
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: exenatide
subcutaneous injection, 5mcg, twice a day
Other Names:
  • LY2148568
  • Byetta
Experimental: 2 Drug: exenatide
subcutaneous injection, 10mcg, twice a day
Other Names:
  • LY2148568
  • Byetta
Placebo Comparator: 3 Drug: placebo
subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577824

Locations
Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Hyogo, Japan
Research Site
Ibaragi, Japan
Research Site
Kanagawa, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Nagano, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00577824     History of Changes
Other Study ID Numbers: H8O-JE-GWBB
Study First Received: December 18, 2007
Results First Received: November 23, 2009
Last Updated: June 6, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
diabetes
exenatide
LY2148568
Byetta
Lilly
Amylin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014