Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00765817
First received: October 1, 2008
Last updated: September 17, 2013
Last verified: September 2013

October 1, 2008
September 17, 2013
October 2008
January 2010   (final data collection date for primary outcome measure)
Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: baseline and 30 weeks ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00765817 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Achieving HbA1c <=7% [ Time Frame: baseline and 30 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: placebo
    subcutaneous injection, twice a day
  • Drug: exenatide
    subcutaneous injection, twice a day, 10mcg
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: exenatide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Greece,   Israel,   Mexico,   Puerto Rico,   United Kingdom
 
NCT00765817
H80-US-GWCO
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
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
Bristol-Myers Squibb
September 2013

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