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

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ClinicalTrials.gov Identifier: NCT00870194
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : June 17, 2011
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

March 25, 2009
March 27, 2009
April 11, 2011
June 17, 2011
April 9, 2015
March 2009
April 2010   (Final data collection date for primary outcome measure)
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%]
Test hypothesis that switching to exenatide & metformin is non-inferior to adding exenatide to sitagliptin & metformin, as measured by a change in HbA1c from baseline to endpoint, in patients w/type 2 diabetes experiencing inadequate glycemic control [ Time Frame: 20 Weeks ]
Complete list of historical versions of study NCT00870194 on ClinicalTrials.gov Archive Site
  • 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
  • To compare treatment arms in terms of proportion of patients achieving HbA1c ≤7.0%, <7.0% and ≤6.5% at endpoint [ Time Frame: 20 Weeks ]
  • To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose [ Time Frame: 20 Weeks ]
  • To compare treatment arms in terms of change from baseline to endpoint in body weight [ Time Frame: 20 Weeks ]
  • To compare treatment arms in terms of change from baseline to endpoint in waist circumference and waist-to-hip ratio [ Time Frame: 20 Weeks ]
  • To compare treatment arms in terms of 7-point self-monitored blood glucose (SMBG) profiles and mean blood glucose measurement based on 7-point SMBG [ Time Frame: 20 Weeks ]
  • To compare treatment arms in terms of change from baseline to endpoint in serum lipids [ Time Frame: 20 Weeks ]
  • To compare treatment arms in terms of safety and tolerability [ Time Frame: 20 Weeks ]
Not Provided
Not Provided
 
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: exenatide and sitagliptin
  • Placebo Comparator: 2
    Intervention: Drug: exenatide and placebo
Violante R, Oliveira JH, Yoon KH, Reed VA, Yu MB, Bachmann OP, Lüdemann J, Chan JY. A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitagliptin. Diabet Med. 2012 Nov;29(11):e417-24. doi: 10.1111/j.1464-5491.2012.03624.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
240
April 2010
April 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Germany,   Greece,   India,   Korea, Republic of,   Mexico
 
 
NCT00870194
H8O-CR-GWDK
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Chief Medical Officer, MD Eli Lilly and Company
AstraZeneca
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP