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Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00765817
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : January 26, 2011
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 3, 2008
Results First Submitted Date  ICMJE January 4, 2011
Results First Posted Date  ICMJE January 26, 2011
Last Update Posted Date October 24, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: baseline and 30 weeks ]
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Test the hypothesis that twice daily exenatide plus titration of basal insulin is superior to placebo plus titration of basal insulin on glycemic control [ Time Frame: 30 weeks ]
Change History Complete list of historical versions of study NCT00765817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
  • Percentage of Patients Achieving HbA1c <=7% [ Time Frame: baseline and 30 weeks ]
    Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).
  • Percentage of Patients Achieving HbA1c <=6.5% [ Time Frame: baseline and 30 weeks ]
    Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).
  • Change in Fasting Serum Glucose [ Time Frame: baseline and 30 weeks ]
    Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
  • Change in 7-point Self-monitored Blood Glucose (SMBG) Profile [ Time Frame: baseline and 30 weeks ]
    Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
  • Change in Total Cholesterol [ Time Frame: baseline and 30 weeks ]
    Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
  • Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: baseline and 30 weeks ]
    Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
  • Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: baseline and 30 weeks ]
    Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
  • Change in Triglycerides [ Time Frame: baseline and 30 weeks ]
    Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
  • Change in Body Weight [ Time Frame: baseline and 30 weeks ]
    Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
  • Change in Waist Circumference [ Time Frame: baseline and 30 weeks ]
    Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
  • Change in Daily Insulin Dose [ Time Frame: baseline and 30 weeks ]
    Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
  • Change in Daily Insulin Dose (on a Per Body Weight Basis) [ Time Frame: baseline and 30 weeks ]
    Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
  • Change in Systolic Blood Pressure (SBP) [ Time Frame: baseline and 30 weeks ]
    Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
  • Change in Diastolic Blood Pressure (DBP) [ Time Frame: baseline and 30 weeks ]
    Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
  • Minor Hypoglycemia Rate Per Year [ Time Frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30 ]
    Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
  • Percentage of Subjects Experiencing Minor Hypoglycemia [ Time Frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30 ]
    Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Compare the efficacy and safety of exenatide to placebo when added to basal insulin glargine with or without OAMs with respect to various pharmacodynamic measures. [ Time Frame: 30 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
Official Title  ICMJE A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications
Brief Summary This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: placebo
    subcutaneous injection, twice a day
  • Drug: exenatide
    subcutaneous injection, twice a day, 10mcg
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: exenatide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2013)
261
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
260
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have type 2 diabetes.
  • Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

  1. metformin (stable dose for 6 weeks)
  2. pioglitazone (stable dose for 6 weeks)
  3. a combination of metformin and pioglitazone (stable dose for 6 weeks)

    • Have HbA1C between 7.1% and 10.5%, inclusive.
    • Have a body mass index (BMI) ≤45 kg/m2.
    • Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

  • Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
  • Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
  • Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
  • Women who are breastfeeding.
  • Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
  • Have had a kidney transplant or are currently on kidney dialysis.
  • Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
  • Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
  • Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
  • Are currently on a weight-loss program or have been on one within 3 months of entering the study.
  • Have had a blood transfusion or severe blood loss within 3 months of entering the study.
  • Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
  • Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
  • Have a history of pancreatitis.
  • Have received treatment with an experimental drug within 30 days of entering the study.
  • If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
  • If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
  • If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece,   Israel,   Mexico,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765817
Other Study ID Numbers  ICMJE H8O-US-GWCO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account AstraZeneca
Verification Date October 2016

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