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Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
exenatide once weekly
insulin glargine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • present with type 2 diabetes mellitus
  • HbA1c between 7.1% and 11.0% inclusive
  • body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive
  • treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

Exclusion Criteria:

  • Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
  • Have been treated with drugs that promote weight loss within 90 days prior to study start.
  • Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start.
  • Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
  • Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
  • Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
  • Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
  • Have donated blood within 30 days prior to study start.

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

exenatide once weekly

insulin glargine

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Endpoint (Week 26)
Change in HbA1c from baseline to endpoint (Week 26).

Secondary Outcome Measures

Percentage of Subjects Achieving HbA1c<=7%
Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)
Percentage of Subjects Achieving HbA1c<=6.5%
Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)
Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)
Change in FSG (centralized measurement) from baseline to endpoint (Week 26)
Change in Body Weight From Baseline to Endpoint (Week 26)
Change in Body Weight from baseline to endpoint (Week 26)
Change in Total Cholesterol From Baseline to Endpoint (Week 26)
Change in Total Cholesterol from baseline to endpoint (Week 26)
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)
Change in HDL-C from baseline to endpoint (Week 26)
Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline
Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Change in Blood Pressure From Baseline to Endpoint (Week 26)
Change in Blood Pressure from baseline to endpoint (Week 26)
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

Full Information

First Posted
July 8, 2009
Last Updated
May 21, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00935532
Brief Title
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
Official Title
Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exenatide once weekly
Arm Type
Experimental
Arm Title
insulin glargine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide once weekly
Intervention Description
subcutaneous injection, 2.0mg, once a week;
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
insulin glargine-Lantus
Intervention Description
subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Endpoint (Week 26)
Description
Change in HbA1c from baseline to endpoint (Week 26).
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving HbA1c<=7%
Description
Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)
Time Frame
Baseline, Week 26
Title
Percentage of Subjects Achieving HbA1c<=6.5%
Description
Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)
Time Frame
Baseline, Week 26
Title
Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)
Description
Change in FSG (centralized measurement) from baseline to endpoint (Week 26)
Time Frame
Baseline, Week 26
Title
Change in Body Weight From Baseline to Endpoint (Week 26)
Description
Change in Body Weight from baseline to endpoint (Week 26)
Time Frame
Baseline, Week 26
Title
Change in Total Cholesterol From Baseline to Endpoint (Week 26)
Description
Change in Total Cholesterol from baseline to endpoint (Week 26)
Time Frame
Baseline, Week 26
Title
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)
Description
Change in HDL-C from baseline to endpoint (Week 26)
Time Frame
Baseline, Week 26
Title
Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline
Description
Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Time Frame
Baseline, Week 26
Title
Change in Blood Pressure From Baseline to Endpoint (Week 26)
Description
Change in Blood Pressure from baseline to endpoint (Week 26)
Time Frame
Baseline, Week 26
Title
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Description
Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.
Time Frame
Baseline to Week 26
Title
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
Description
Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick 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 postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.
Time Frame
Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: present with type 2 diabetes mellitus HbA1c between 7.1% and 11.0% inclusive body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start Exclusion Criteria: Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start. Have been treated with drugs that promote weight loss within 90 days prior to study start. Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start. Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered). Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication. Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start. Have donated blood within 30 days prior to study start.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aomori
Country
Japan
Facility Name
Research Site
City
Chiba
Country
Japan
Facility Name
Research Site
City
Ehime
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Gunma
Country
Japan
Facility Name
Research Site
City
Hiroshima
Country
Japan
Facility Name
Research Site
City
Hokkaido
Country
Japan
Facility Name
Research Site
City
Hyogo
Country
Japan
Facility Name
Research Site
City
Ibaragi
Country
Japan
Facility Name
Research Site
City
Kagawa
Country
Japan
Facility Name
Research Site
City
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kumamoto
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Nagano
Country
Japan
Facility Name
Research Site
City
Nagasaki
Country
Japan
Facility Name
Research Site
City
Nara
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Saitama
Country
Japan
Facility Name
Research Site
City
Shizuoka
Country
Japan
Facility Name
Research Site
City
Tokyo
Country
Japan
Facility Name
Research Site
City
Toyama
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32306296
Citation
Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013.
Results Reference
derived
PubMed Identifier
22884767
Citation
Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9.
Results Reference
derived

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

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