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OpenTrials
Completed

NCT Number: NCT00360334

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aberdeen, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with type 2 diabetes
  • Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
  • HbA1c between 7.5% and 10.0%.
  • BMI >27.

Exclusion criteria

  • Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
  • Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5mcg or 10mcg, twice a day

Other names: Byetta

insulin glargine

Drug

subcutaneous injection, titrated to target blood glucose level, once a day

Other names: Lantus

Primary outcomes

  1. Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)

    Time frame: 26 weeks

    Composite endpoint evaluating effect of treatment on glycemic control and weight

Secondary outcomes

  1. Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg

    Time frame: 26 weeks

    Composite endpoint evaluating effect of treatment on glycemic control and weight

  2. Change in Fasting Serum Glucose

    Time frame: 26 weeks

    Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)

  3. Percent of Patients Achieving HbA1c ≤ 7.4%

    Time frame: 26 weeks

    Percent of patients achieving specified HbA1c target at endpoint

  4. Percent of Patients Achieving HbA1c < 7%

    Time frame: 26 weeks

    Percent of patients achieving specified HbA1c target at endpoint

  5. Percent of Patients Achieving HbA1c < 6.5%

    Time frame: 26 weeks

    Percent of patients achieving specified HbA1c target at endpoint

  6. Change in 7 Point Self Monitored Blood Glucose Profile

    Time frame: 26 weeks

    Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day

  7. Change in Body Mass Index (BMI)

    Time frame: 26 weeks

    Change in BMI from baseline to endpoint

  8. Change in Waist Circumference

    Time frame: 26 Weeks

    Change in waist circumference from baseline to endpoint

  9. Change in Waist-to-hip Ratio

    Time frame: 26 weeks

    Change in waist-to-hip ratio from baseline to endpoint

  10. Change in Body Weight

    Time frame: 26 weeks

    Change in body weight from baseline to endpoint

  11. Percent Change in Body Weight

    Time frame: 26 Weeks

    Percent change in baseline body weight at endpoint

  12. Percent of Patients Achieving 5% Weight Loss

    Time frame: 26 weeks

    Percent of patients who lost at least 5% of baseline body weight at endpoint

  13. Percent of Patients Achieving 10% Weight Loss

    Time frame: 26 weeks

    Percent of patients who lost at least 10% of baseline body weight at endpoint

  14. Change in Systolic Blood Pressure

    Time frame: 26 weeks

    Change in systolic blood pressure from baseline to endpoint

  15. Change in Diastolic Blood Pressure

    Time frame: 26 weeks

    Change in diastolic blood pressure from baseline to endpoint

  16. Change in Fasting Serum Total Cholesterol (TC)

    Time frame: 26 weeks

    Change in TC from baseline to endpoint

  17. Change in High Density Lipoprotein (HDL) Cholesterol

    Time frame: 26 weeks

    Change in HDL cholesterol from baseline to endpoint

  18. Change in TC to HDL Cholesterol Ratio

    Time frame: 26 weeks

    Change in TC to HDL cholesterol ratio from baseline to endpoint

  19. Change in Fasting Serum Triglycerides

    Time frame: 26 weeks

    Change in fasting serum triglycerides from baseline to endpoint

  20. Change in Low Density Lipoprotein (LDL) Cholesterol

    Time frame: 26 weeks

    Change in LDL cholesterol from baseline to endpoint

  21. Change in Apolipoprotein-B

    Time frame: 26 weeks

    Change in apolipoprotein-B from baseline to endpoint

  22. Incidence of Hypoglycemic Episodes

    Time frame: 26 weeks

    Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study

  23. Incidence of Nocturnal Hypoglycemic Episodes

    Time frame: 26 weeks

    Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study

  24. Incidence of Severe Hypoglycemic Episodes

    Time frame: 26 weeks

    Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study

  25. Hypoglycemic Rate Per 30 Days

    Time frame: 26 weeks

    Number of hypoglycemic episodes per patient adjusted per 30 days

  26. Nocturnal Hypoglycemic Rate Per 30 Days

    Time frame: 26 weeks

    Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days

  27. Severe Hypoglycemic Rate Per 30 Days

    Time frame: 26 weeks

    Number of severe hypoglycemic episodes per patient adjusted per 30 days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 4, 2006
Registry last updated
Apr 7, 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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