Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00870194
First received: March 25, 2009
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide and sitagliptin
Drug: exenatide and placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c (Percent) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]


Secondary Outcome Measures:
  • Percentage of Patients Achieving HbA1c <=7.0% [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)

  • Change in Body Weight (kg) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline to endpoint (Week 20)

  • Change in Waist Circumference (cm) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Change in waist circumference from baseline to endpoint (Week 20)

  • Waist-to-Hip Ratio [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Change in waist-to-hip ratio from baseline to endpoint (Week20)

  • SMBG (mmol/L) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)

  • Change in Triglycerides (mmol/L) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Change in triglycerides from baseline to endpoint (Week 20)

  • Change in HDL (mmol/L) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)

  • Change in LDL (mmol/L) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in total cholesterol from baseline to endpoint (Week 20)

  • Incidence of Hypoglycemia (Overall) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Incidence of hypoglycemic episodes experienced overall during the study

  • Incidence of Severe Hypoglycemia(Overall) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Incidence of severe hypoglycemia experienced overall during the study

  • Incidence of Nocturnal Hypoglycemia (Overall) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Incidence of nocturnal hypoglycemia experienced overall during the study

  • Incidence of Confirmed Hypoglycemia(Overall) [ Time Frame: Baseline to 20 Weeks ] [ Designated as safety issue: No ]
    Incidence of confirmed hypoglycemia experienced overall during the study


Enrollment: 255
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Other Name: exenatide-Byetta; sitagliptin-Januvia
Placebo Comparator: 2 Drug: exenatide and placebo
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
Other Name: exenatide-Byetta

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00870194

Locations
Argentina
Research Site
Buenos Aires, Argentina
Research Site
Morón, Argentina
Australia
Research Site
Adelaide, Australia
Research Site
Geelong, Australia
Research Site
Melbourne, Australia
Germany
Research Site
Aschaffenburg, Germany
Research Site
Asslar, Germany
Research Site
Beckum-Neubeckum, Germany
Research Site
Berlin, Germany
Research Site
Bosenheim, Germany
Research Site
Essen, Germany
Research Site
Falkensee, Germany
Research Site
Furth im Wald, Germany
Research Site
Grevenbroich, Germany
Research Site
Hamburg-Othmarschen, Germany
Research Site
Hohenmolsen, Germany
Research Site
Leipzig, Germany
Research Site
Neuwied, Germany
Research Site
Pohlheim, Germany
Research Site
Speyer, Germany
Greece
Research Site
Athens, Greece
Research Site
Thessaloniki, Greece
India
Research Site
Ahmedabad, India
Research Site
Bangalore, India
Research Site
Coimbatore, India
Research Site
Indore, India
Research Site
Jaipur, India
Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Ulsan, Korea, Republic of
Mexico
Research Site
Coatzacoalcos, Mexico
Research Site
Guadalajara, Mexico
Research Site
Merida, Mexico
Research Site
Monterrey, Mexico
Research Site
Tampico, Mexico
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: NCT00870194     History of Changes
Other Study ID Numbers: H8O-CR-GWDK
Study First Received: March 25, 2009
Results First Received: April 11, 2011
Last Updated: June 6, 2014
Health Authority: Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
India: Drugs Controller General of India
South Korea: Korea Food and Drug Administration (KFDA)
Mexico: Ministry of Health

Keywords provided by AstraZeneca:
diabetes
exenatide
Byetta
sitagliptin
Januvia
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014