A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:6/3/2016
Start Date:November 2008
End Date:March 2011

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared
to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately
controlled with metformin and sulphonylurea combination therapy. Patients will be randomized
to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg
once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition
to continued prestudy metformin treatment. The anticipated time on study treatment is 2+
years, and the target sample size if 500+ individuals.


Inclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at
least 12 weeks;

- C-peptide (fasting) >=1.0ng/mL;

- HbA1c >=7.0% and <=10.0% at screening;

- BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;

- stable weight +-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as
ketoacidosis or hyperosmolar coma in the previous 6 months;

- evidence of clinically significant diabetic complications;

- symptomatic poorly controlled diabetes;

- clinically symptomatic gastrointestinal disease;

- myocardial infarction, coronary artery bypass surgery, post-transplantation
cardiomyopathy or stroke within the previous 6 months;

- known hemoglobinopathy or chronic anemia.
We found this trial at
67
sites
2508
mi
from 98109
Palm Harbor, FL
Click here to add this to my saved trials
2348
mi
from 98109
Albany, NY
Click here to add this to my saved trials
2205
mi
from 98109
Altoona, PA
Click here to add this to my saved trials
1474
mi
from 98109
Arkansas City, KS
Click here to add this to my saved trials
2187
mi
from 98109
Asheville, NC
Click here to add this to my saved trials
2178
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
1857
mi
from 98109
Avon, IN
Click here to add this to my saved trials
2378
mi
from 98109
Bensalem, PA
Click here to add this to my saved trials
2383
mi
from 98109
Blackwood, NJ
Click here to add this to my saved trials
1966
mi
from 98109
Centerville, OH
Click here to add this to my saved trials
2380
mi
from 98109
Cherry Hill, NJ
Click here to add this to my saved trials
1967
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
1519
mi
from 98109
Concord, CA
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
1966
mi
from 98109
Crestview Hills, KY
Click here to add this to my saved trials
1682
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
1172
mi
from 98109
Fargo, ND
Click here to add this to my saved trials
Feasterville, Pennsylvania 19053
2376
mi
from 98109
Feasterville, PA
Click here to add this to my saved trials
2409
mi
from 98109
Flushing, NY
Click here to add this to my saved trials
1942
mi
from 98109
Genoa, OH
Click here to add this to my saved trials
1268
mi
from 98109
Grand Island, NE
Click here to add this to my saved trials
2466
mi
from 98109
Green Cove Springs, FL
Click here to add this to my saved trials
2286
mi
from 98109
Harrisburg, NC
Click here to add this to my saved trials
2282
mi
from 98109
Harrisburg, PA
Click here to add this to my saved trials
885
mi
from 98109
Henderson, NV
Click here to add this to my saved trials
2725
mi
from 98109
Hialeah, FL
Click here to add this to my saved trials
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
991
mi
from 98109
Huntington Beach, CA
Click here to add this to my saved trials
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
1983
mi
from 98109
Jackson, MS
Click here to add this to my saved trials
2449
mi
from 98109
Jacksonville, FL
Click here to add this to my saved trials
2140
mi
from 98109
Jefferson Hills, PA
Click here to add this to my saved trials
2169
mi
from 98109
Johnson City, TN
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
719
mi
from 98109
Los Gatos, CA
Click here to add this to my saved trials
2091
mi
from 98109
Metairie, LA
Click here to add this to my saved trials
2417
mi
from 98109
Mineola, NY
Click here to add this to my saved trials
2382
mi
from 98109
Moorestown, NJ
Click here to add this to my saved trials
2349
mi
from 98109
North East, MD
Click here to add this to my saved trials
1366
mi
from 98109
Omaha, NE
Click here to add this to my saved trials
2351
mi
from 98109
Orangeburg, SC
Click here to add this to my saved trials
2524
mi
from 98109
Ormond Beach, FL
Click here to add this to my saved trials
2549
mi
from 98109
Oviedo, FL
Click here to add this to my saved trials
2373
mi
from 98109
Philadelphia, PA
Click here to add this to my saved trials
1116
mi
from 98109
Phoenix, AZ
Click here to add this to my saved trials
2089
mi
from 98109
Picayune, MS
Click here to add this to my saved trials
2482
mi
from 98109
Portland, ME
Click here to add this to my saved trials
1619
mi
from 98109
Quincy, IL
Click here to add this to my saved trials
2348
mi
from 98109
Richmond, VA
Click here to add this to my saved trials
617
mi
from 98109
Roseville, CA
Click here to add this to my saved trials
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
987
mi
from 98109
Santa Ana, CA
Click here to add this to my saved trials
2303
mi
from 98109
Scranton, PA
Click here to add this to my saved trials
1784
mi
from 98109
Searcy, AR
Click here to add this to my saved trials
1704
mi
from 98109
Springfield, IL
Click here to add this to my saved trials
1634
mi
from 98109
Springfield, MO
Click here to add this to my saved trials
St. Claire Shores, Michigan 48081
1935
mi
from 98109
St. Claire Shores, MI
Click here to add this to my saved trials
St. Leonards, New South Wales 2065
7747
mi
from 98109
St. Leonards,
Click here to add this to my saved trials
1993
mi
from 98109
Sunset, LA
Click here to add this to my saved trials
2205
mi
from 98109
Tipton, PA
Click here to add this to my saved trials
1929
mi
from 98109
Toledo, OH
Click here to add this to my saved trials
2418
mi
from 98109
Toms River, NJ
Click here to add this to my saved trials
?
mi
from 98109
Trinity, FL
Click here to add this to my saved trials
2322
mi
from 98109
Washington,
Click here to add this to my saved trials
1673
mi
from 98109
Waukesha, WI
Click here to add this to my saved trials
Westlake Village, California 91361
949
mi
from 98109
Westlake Village, CA
Click here to add this to my saved trials
Worchester, Massachusetts 01655
2456
mi
from 98109
Worchester, MA
Click here to add this to my saved trials
2525
mi
from 98109
Zephyrhills, FL
Click here to add this to my saved trials