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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: exenatide once weekly; Drug: insulin glargine

• Registration Number: NCT00935532
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Primary Completion: 2010-09
• Disposition First Submitted: 2011-06-17
• Disposition First Submitted QC: 2011-06-17
• Disposition First Posted: 2011-06-27
• Study Completion: 2011-07
• Results First Submitted: 2012-02-14
• Results First Submitted QC: 2012-09-24
• Results First Posted: 2012-10-24
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exenatide once weekly	exenatide once weekly	-
insulin glargine	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to Endpoint (Week 26)	Baseline, Week 26	Change in HbA1c from baseline to endpoint (Week 26).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Toyama, Japan