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Completed

NCT Number: NCT00577824

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5mcg, twice a day

Other names: LY2148568, Byetta

Placebo

Drug

subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Primary outcomes

  1. Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

    Time frame: baseline, 24 weeks

    Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

Secondary outcomes

  1. Percentage of Patients Achieving HbA1c < 7.0%

    Time frame: 24 weeks

    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)

  2. Percentage of Patients Achieving HbA1c < 6.5%

    Time frame: 24 weeks

    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)

  3. Change in Fasting Blood Glucose

    Time frame: baseline, week 24

    Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)

  4. Change in Body Weight

    Time frame: baseline, week 24

    Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)

  5. Change in Total Cholesterol

    Time frame: baseline, week 24

    Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

  6. Change in Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: baseline, week 24

    Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)

  7. Change in High Density Lipoprotein Cholesterol (HDL-C)

    Time frame: baseline, week 24

    Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)

  8. Change in Triglycerides

    Time frame: baseline, week 24

    Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)

  9. Change in Waist Size

    Time frame: baseline, week 24

    Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)

  10. Change in Waist-to-hip Ratio

    Time frame: baseline, week 24

    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.

  11. 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24

    Time frame: baseline, week 24

    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).

  12. Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)

    Time frame: baseline, week 24

    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.

  13. Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)

    Time frame: baseline, week 24

    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.

  14. Change in Serum Insulin

    Time frame: baseline, week 24

    Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)

  15. Change in C-peptide

    Time frame: baseline, week 24

    Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)

  16. Change in 1,5-anhydroglucitol

    Time frame: baseline, week 24

    Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 20, 2007
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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