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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: placebo
Drug: exenatide
Phase 3

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 Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 261
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
subcutaneous injection, twice a day
Experimental: 2 Drug: exenatide
subcutaneous injection, twice a day, 10mcg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765817

  Hide Study Locations
Locations
United States, Arizona
Research Site
Peoria, Arizona, United States
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
Buena Park, California, United States
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, United States
Research Site
La Mesa, California, United States
Research Site
Lancaster, California, United States
Research Site
Northridge, California, United States
Research Site
Palm Springs, California, United States
Research Site
Salinas, California, United States
United States, Florida
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Hawaii
Research Site
Honolulu, Hawaii, United States
United States, Idaho
Research Site
Idaho Falls, Idaho, United States
United States, Iowa
Research Site
Des Moines, Iowa, United States
United States, Kansas
Research Site
Wichita, Kansas, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
Research Site
Lafayette, Louisiana, United States
Research Site
Matairie, Louisiana, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, Missouri
Research Site
Chesterfield, Missouri, United States
Research Site
St Louis, Missouri, United States
United States, Nebraska
Research Site
Omaha, Nebraska, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States
United States, New Jersey
Research Site
Berkeley Heights, New Jersey, United States
Research SIte
Teaneck, New Jersey, United States
United States, New Mexico
Research Site
Alburquerque, New Mexico, United States
United States, New York
Research SIte
New York, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Oregon
Research Site
Bend, Oregon, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Georgetown, Texas, United States
Research Site
San Antonio, Texas, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
United States, Washington
Research Site
Vancouver, Washington, United States
United States, Wisconsin
Research Site
Kenosha, Wisconsin, United States
Greece
Research Site
Athens, Greece
Research Site
Thessaloniki, Greece
Israel
Research Site
Holon, Israel
Research Site
Kfar Sava, Israel
Research Site
Tel Hashomer, Israel
Mexico
Research Site
Coatzacoalcos, Mexico
Research Site
Mexico, Mexico
Research Site
Monterrey, Mexico
Puerto Rico
Research Site
Carolina, Puerto Rico
Research Site
Hato Rey, Puerto Rico
Research Site
Ponce, Puerto Rico
Research Site
San Juan, Puerto Rico
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Livingston, United Kingdom
Research Site
Middlesbrough, United Kingdom
Research Site
Swansea, United Kingdom
Research Site
Torquay, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Eli Lilly and Company
Investigators
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
  More Information

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00765817     History of Changes
Other Study ID Numbers: H80-US-GWCO
Study First Received: October 1, 2008
Results First Received: January 4, 2011
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Greece: Ethics Committee
Mexico: Ethics Committee
Israel: Ministry of Health

Keywords provided by Bristol-Myers Squibb:
diabetes
exenatide
Amylin
Lilly
metformin
pioglitazone
insulin glargine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Glargine
Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014