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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ClinicalTrials.gov Identifier: NCT00935532

Recruitment Status : Completed

First Posted : July 9, 2009

Results First Posted : October 24, 2012

Last Update Posted : June 15, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

AstraZeneca

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: exenatide once weekly Drug: insulin glargine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	427 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	July 2009
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	July 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Insulin Insulin human Exenatide Insulin glargine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: exenatide once weekly	Drug: exenatide once weekly subcutaneous injection, 2.0mg, once a week;
Active Comparator: insulin glargine	Drug: insulin glargine subcutaneous injection, titrated to achieve fasting serum glucose target, once a day Other Name: insulin glargine-Lantus

Outcome Measures

Primary Outcome Measures :

Change in HbA1c From Baseline to Endpoint (Week 26) [ Time Frame: Baseline, Week 26 ]
Change in HbA1c from baseline to endpoint (Week 26).

Secondary Outcome Measures :

Percentage of Subjects Achieving HbA1c<=7% [ Time Frame: Baseline, Week 26 ]
Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)
Percentage of Subjects Achieving HbA1c<=6.5% [ Time Frame: Baseline, Week 26 ]
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) [ Time Frame: Baseline, Week 26 ]
Change in FSG (centralized measurement) from baseline to endpoint (Week 26)
Change in Body Weight From Baseline to Endpoint (Week 26) [ Time Frame: Baseline, Week 26 ]
Change in Body Weight from baseline to endpoint (Week 26)
Change in Total Cholesterol From Baseline to Endpoint (Week 26) [ Time Frame: Baseline, 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) [ Time Frame: Baseline, Week 26 ]
Change in HDL-C from baseline to endpoint (Week 26)
Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline [ Time Frame: Baseline, Week 26 ]
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) [ Time Frame: Baseline, Week 26 ]
Change in Blood Pressure from baseline to endpoint (Week 26)
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events [ Time Frame: Baseline to Week 26 ]
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 [ Time Frame: Baseline to Week 26 ]
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.

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935532

Locations

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Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Ehime, Japan
Research Site
Fukuoka, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
Ibaragi, Japan
Research Site
Kagawa, Japan
Research Site
Kanagawa, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Research Site
Saitama, Japan
Research Site
Shizuoka, Japan
Research Site
Tokyo, Japan
Research Site
Toyama, Japan

Sponsors and Collaborators

AstraZeneca

Eli Lilly and Company

Investigators

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Study Director:	Chief Medical Officer, MD	Eli Lilly and Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00935532
Other Study ID Numbers:	H8O-JE-GWBX
First Posted:	July 9, 2009 Key Record Dates
Results First Posted:	October 24, 2012
Last Update Posted:	June 15, 2015
Last Verified:	May 2015

Keywords provided by AstraZeneca:


diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly

Additional relevant MeSH terms:

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Insulin, Globin Zinc Insulin Glargine	Exenatide Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

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