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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00935532
First received: July 8, 2009
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide once weekly
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c From Baseline to Endpoint (Week 26) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline to endpoint (Week 26).


Secondary Outcome Measures:
  • Percentage of Subjects Achieving HbA1c<=7% [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 427
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935532

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00935532     History of Changes
Other Study ID Numbers: H8O-JE-GWBX
Study First Received: July 8, 2009
Results First Received: February 14, 2012
Last Updated: June 6, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Exenatide
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014