Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agent Failure



Status:Archived
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2010
End Date:June 2012

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A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide


Primary objective:

To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage
of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative
period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents

Secondary objectives of the comparative period (24 weeks):

>To assess the effect of insulin glargine in comparison with liraglutide on:

- HbA1c level

- Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the
comparative period

- Percentage of patients whose HbA1c has increased at the end of the comparative period

- Fasting Plasma Glucose (FPG)

- 7-point Plasma Glucose (PG) profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events

Objectives of the extension period (24 weeks):

>To assess the effect of insulin glargine in patients not adequately controlled with
liraglutide on:

- HbA1c level

- FPG

- 7-point PG profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events


The maximum estimated study duration per patient will be approximately 51 weeks broken down
as follow:

- A 2-week of screening period,

- A 24-week comparative period,

- A 24-week extension period (only for patients treated with liraglutide, not adequately
controlled at the end of the comparative period),

- A 1-week follow-up period


We found this trial at
33
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949
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Rapid City, SD
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9143 Philips Hwy # 560
Jacksonville Beach, Florida 32250
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Jacksonville Beach, FL
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Albany, NY
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Arlington Heights, Illinois 60004
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Arlington Heights, IL
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2392
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Atco, NJ
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2072
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Birmingham, AL
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1888
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Bryan, OH
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1681
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Dallas, TX
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1678
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Dallas, TX
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1398
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Eagan, MN
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1103
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Goodyear, AZ
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908
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Grand Junction, CO
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2238
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Hickory, NC
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1056
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La Jolla, CA
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1063
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La Mesa, CA
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2184
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Lawrenceville, GA
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Loma Linda, CA
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997
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Longmont, CO
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2417
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Mineola, NY
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1393
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Minneapolis, MN
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Mission Viejo, California 92691
998
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Mission Viejo, CA
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1854
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Paducah, KY
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999
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Palm Springs, CA
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1109
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Phoenix, AZ
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28
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Renton, WA
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
2352
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Richmond, VA
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2309
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Rockville, MD
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2170
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Roswell, GA
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228
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Spokane, WA
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1717
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St Louis, MO
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2400
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Staten Island, NY
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988
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Tustin, CA
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2162
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Uniontown, PA
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