Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
NCT ID: NCT00765817
Last Updated: 2016-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
261 participants
INTERVENTIONAL
2008-10-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
placebo
subcutaneous injection, twice a day
2
exenatide
subcutaneous injection, twice a day, 10mcg
Interventions
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placebo
subcutaneous injection, twice a day
exenatide
subcutaneous injection, twice a day, 10mcg
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Peoria, Arizona, United States
Research Site
Phoenix, Arizona, United States
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
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Des Moines, Iowa, United States
Research Site
Wichita, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Lafayette, Louisiana, United States
Research Site
Matairie, Louisiana, United States
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Boston, Massachusetts, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Chesterfield, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Berkeley Heights, New Jersey, United States
Research SIte
Teaneck, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research SIte
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Bend, Oregon, United States
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
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Richmond, Virginia, United States
Research Site
Vancouver, Washington, United States
Research Site
Kenosha, Wisconsin, United States
Research Site
Athens, Greece, Greece
Research Site
Thessaloniki, Greece, Greece
Research Site
Holon, Israel, Israel
Research Site
Kfar Saba, Israel, Israel
Research Site
Tel Litwinsky, Israel, Israel
Research Site
Coatzacoalcos, Mexico, Mexico
Research Site
Monterrey, Mexico, Mexico
Research Site
México, State of Mexico, Mexico
Research Site
Carolina, , Puerto Rico
Research Site
Hato Rey, , Puerto Rico
Research Site
Ponce, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Research Site
Birmingham, United Kingdom, United Kingdom
Research Site
Guildford, United Kingdom, United Kingdom
Research Site
Leicester, United Kingdom, United Kingdom
Research Site
Livingston, United Kingdom, United Kingdom
Research Site
Middlesbrough, United Kingdom, United Kingdom
Research Site
Swansea, United Kingdom, United Kingdom
Research Site
Torquay, United Kingdom, United Kingdom
Countries
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References
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Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.
Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5.
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19.
Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6.
Other Identifiers
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H8O-US-GWCO
Identifier Type: -
Identifier Source: org_study_id
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