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OpenTrials
Completed

NCT Number: NCT00870194

A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

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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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

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
  • Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
  • 100 mg/day sitagliptin and
  • ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
  • Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
  • Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2

Exclusion criteria

  • Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have previously completed or withdrawn from this study or any other study investigating exenatide.
  • Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
  • Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
  • Are currently treated with any of the following excluded medications:
  • Thiazolidinediones (TZD) within 3 months of screening.
  • Sulfonylurea (SU) within 3 months of screening.
  • Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.
  • Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
  • Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
  • Exogenous insulin within the 3 months prior to screening.
  • Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
  • Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
  • Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Treatment and study plan

exenatide and sitagliptin

Drug

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day

Other names: exenatide-Byetta; sitagliptin-Januvia

exenatide and placebo

Drug

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Other names: exenatide-Byetta

Primary outcomes

  1. Change in HbA1c (Percent)

    Time frame: Baseline to 20 Weeks

    Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]

Secondary outcomes

  1. Percentage of Patients Achieving HbA1c <=7.0%

    Time frame: Baseline to 20 Weeks

    Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)

  2. Percentage of Patients Achieving HbA1c <7.0%

    Time frame: Baseline to 20 Weeks

    Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)

  3. Percentage of Patients Achieving HbA1c <=6.5%

    Time frame: Baseline to 20 Weeks

    Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)

  4. Change in FSG (mmol/L)

    Time frame: Baseline to 20 Weeks

    Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)

  5. Change in Body Weight (kg)

    Time frame: Baseline to 20 Weeks

    Change in body weight from baseline to endpoint (Week 20)

  6. Change in Waist Circumference (cm)

    Time frame: Baseline to 20 Weeks

    Change in waist circumference from baseline to endpoint (Week 20)

  7. Waist-to-Hip Ratio

    Time frame: Baseline to 20 Weeks

    Change in waist-to-hip ratio from baseline to endpoint (Week20)

  8. SMBG (mmol/L)

    Time frame: Baseline to 20 Weeks

    7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)

  9. Change in Triglycerides (mmol/L)

    Time frame: Baseline to 20 Weeks

    Change in triglycerides from baseline to endpoint (Week 20)

  10. Change in HDL (mmol/L)

    Time frame: Baseline to 20 Weeks

    Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)

  11. Change in LDL (mmol/L)

    Time frame: Baseline to 20 Weeks

    Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)

  12. Change in Total Cholesterol (mmol/L)

    Time frame: Baseline to 20 Weeks

    Change in total cholesterol from baseline to endpoint (Week 20)

  13. Incidence of Hypoglycemia (Overall)

    Time frame: Baseline to 20 Weeks

    Incidence of hypoglycemic episodes experienced overall during the study

  14. Incidence of Severe Hypoglycemia(Overall)

    Time frame: Baseline to 20 Weeks

    Incidence of severe hypoglycemia experienced overall during the study

  15. Incidence of Nocturnal Hypoglycemia (Overall)

    Time frame: Baseline to 20 Weeks

    Incidence of nocturnal hypoglycemia experienced overall during the study

  16. Incidence of Confirmed Hypoglycemia(Overall)

    Time frame: Baseline to 20 Weeks

    Incidence of confirmed hypoglycemia experienced overall during the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 27, 2009
Registry last updated
Apr 9, 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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