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

Type 2 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935532
• Other study ID #: H8O-JE-GWBX
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2009
• Last updated: May 21, 2015
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: July 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide once weekly
subcutaneous injection, 2.0mg, once a week;
• insulin glargine
subcutaneous injection, titrated to achieve fasting serum glucose target, once a day

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c From Baseline to Endpoint (Week 26)	Change in HbA1c from baseline to endpoint (Week 26).	Baseline, Week 26	No
Secondary	Percentage of Subjects Achieving HbA1c<=7%	Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)	Baseline, Week 26	No
Secondary	Percentage of Subjects Achieving HbA1c<=6.5%	Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)	Baseline, Week 26	No
Secondary	Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)	Change in FSG (centralized measurement) from baseline to endpoint (Week 26)	Baseline, Week 26	No
Secondary	Change in Body Weight From Baseline to Endpoint (Week 26)	Change in Body Weight from baseline to endpoint (Week 26)	Baseline, Week 26	No
Secondary	Change in Total Cholesterol From Baseline to Endpoint (Week 26)	Change in Total Cholesterol from baseline to endpoint (Week 26)	Baseline, Week 26	No
Secondary	Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)	Change in HDL-C from baseline to endpoint (Week 26)	Baseline, Week 26	No
Secondary	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.	Baseline, Week 26	No
Secondary	Change in Blood Pressure From Baseline to Endpoint (Week 26)	Change in Blood Pressure from baseline to endpoint (Week 26)	Baseline, Week 26	No
Secondary	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.	Baseline to Week 26	Yes
Secondary	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.	Baseline to Week 26	Yes