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Completed

NCT Number: NCT00935532

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aomori, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide once weekly

Drug

subcutaneous injection, 2.0mg, once a week;

insulin glargine

Drug

subcutaneous injection, titrated to achieve fasting serum glucose target, once a day

Other names: insulin glargine-Lantus

Primary outcomes

  1. Change in HbA1c From Baseline to Endpoint (Week 26)

    Time frame: Baseline, Week 26

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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  8. 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)

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 9, 2009
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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