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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2010

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • 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)
  • 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)
  • Change in FSG (mmol/L)
    • Time Frame: Baseline to 20 Weeks
    • Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
  • Change in Body Weight (kg)
    • Time Frame: Baseline to 20 Weeks
    • Change in body weight from baseline to endpoint (Week 20)
  • Change in Waist Circumference (cm)
    • Time Frame: Baseline to 20 Weeks
    • Change in waist circumference from baseline to endpoint (Week 20)
  • Waist-to-Hip Ratio
    • Time Frame: Baseline to 20 Weeks
    • Change in waist-to-hip ratio from baseline to endpoint (Week20)
  • SMBG (mmol/L)
    • Time Frame: Baseline to 20 Weeks
    • 7 point Self Monitored Blood Glucose Profiles – daily mean value (Week 20)
  • Change in Triglycerides (mmol/L)
    • Time Frame: Baseline to 20 Weeks
    • Change in triglycerides from baseline to endpoint (Week 20)
  • Change in HDL (mmol/L)
    • Time Frame: Baseline to 20 Weeks
    • Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
  • Change in LDL (mmol/L)
    • Time Frame: Baseline to 20 Weeks
    • Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
  • Change in Total Cholesterol (mmol/L)
    • Time Frame: Baseline to 20 Weeks
    • Change in total cholesterol from baseline to endpoint (Week 20)
  • Incidence of Hypoglycemia (Overall)
    • Time Frame: Baseline to 20 Weeks
    • Incidence of hypoglycemic episodes experienced overall during the study
  • Incidence of Severe Hypoglycemia(Overall)
    • Time Frame: Baseline to 20 Weeks
    • Incidence of severe hypoglycemia experienced overall during the study
  • Incidence of Nocturnal Hypoglycemia (Overall)
    • Time Frame: Baseline to 20 Weeks
    • Incidence of nocturnal hypoglycemia experienced overall during the study
  • Incidence of Confirmed Hypoglycemia(Overall)
    • Time Frame: Baseline to 20 Weeks
    • Incidence of confirmed hypoglycemia experienced overall during the study

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chief Medical Officer, MD, Study Director, Eli Lilly and Company

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