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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: placebo; Drug: exenatide

• Registration Number: NCT00577824
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-20
• Study Start: 2008-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-11-23
• Results First Submitted QC: 2009-11-23
• Results First Posted: 2009-12-31
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	-
1	exenatide	-
2	exenatide	-

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24	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 Outcome Measures

Name	Time	Method
Change in Body Weight	baseline, week 24	Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)
Change in High Density Lipoprotein Cholesterol (HDL-C)	baseline, week 24	Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)
Percentage of Patients Achieving HbA1c < 7.0%	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)
Percentage of Patients Achieving HbA1c < 6.5%	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)
Change in Fasting Blood Glucose	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)
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24	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).
Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)	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.
Change in C-peptide	baseline, week 24	Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)
Change in Low Density Lipoprotein Cholesterol (LDL-C)	baseline, week 24	Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)
Change in Waist-to-hip Ratio	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.
Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)	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.
Change in Total Cholesterol	baseline, week 24	Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
Change in Triglycerides	baseline, week 24	Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)
Change in Serum Insulin	baseline, week 24	Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)
Change in Waist Size	baseline, week 24	Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)
Change in 1,5-anhydroglucitol	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)

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan