Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:1/27/2017
Start Date:February 2001
End Date:October 2001

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NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to
determine the dose-response relationship for body weight and five escalating doses of NNC
90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral
hypoglycemic agent (OHA).


Inclusion Criteria:

- Type 2 diabetic

- Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior
use of metformin is allowed

- Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)

- HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

- Cardiac problems

- Uncontrolled treated/untreated hypertension

- Proliferative retinopathy or known autonomic neuropathy

- Recurrent severe hypoglycemia as judged by the investigator

- Known or suspected allergy to trial product or related products

- Use of any drug (except for OHAs), which in the investigators opinion could interfere
with the glucose level or body weight or any contraindication to metformin use or
intolerance to metformin 1000 mg (prior to trial entry or during run-in period).
Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed

- Known or suspected abuse of alcohol or narcotics

- Current treatment with thiazolidinediones or chronic daily use of insulin (more than
7 days) within three months in the absence of intercurrent illness

- TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL

- Type 1 or other specific causes of diabetes
We found this trial at
35
sites
Worcester, Massachusetts 01655
604
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Worcester, MA
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Alhambra, California 91801
1964
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Alhambra, CA
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Carlisle, Arkansas 72024
597
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Carlisle, AR
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Charleston, West Virginia 25302
134
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Charleston, WV
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Charlotte, North Carolina 28277
348
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Charlotte, NC
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Chattanooga, Tennessee 37404
362
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Chattanooga, TN
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Chicago, Illinois 60612
274
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Chicago, IL
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Corpus Christi, Texas 78404
1174
mi
from 43215
Corpus Christi, TX
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Dallas, Texas 75231
905
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Dallas, TX
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Duluth, Minnesota 55805
654
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Duluth, MN
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Durham, North Carolina 27705
354
mi
from 43215
Durham, NC
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Edmonds, Washington 98026
2009
mi
from 43215
Edmonds, WA
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Jacksonville, Florida 32207
672
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from 43215
Jacksonville, FL
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Jonesboro, Arkansas 72401
506
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Jonesboro, AR
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Melbourne, Florida 32901
832
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Melbourne, FL
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Miami, Florida 33136
992
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Miami, FL
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Mission Viejo, California 92691
1954
mi
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Mission Viejo, CA
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North Plainfield, New Jersey 07060
455
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North Plainfield, NJ
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Ocala, Florida 34471
748
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Ocala, FL
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Oklahoma City, Oklahoma 73112
849
mi
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Oklahoma City, OK
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Pembroke Pines, Florida 33026
978
mi
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Pembroke Pines, FL
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Renton, Washington 98057
2001
mi
from 43215
Renton, WA
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Richmond, Virginia 23219
342
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Richmond, VA
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Salt Lake City, Utah 84132
1513
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Salt Lake City, UT
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San Antonio, Texas 78224
1138
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San Antonio, TX
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Springfield, Illinois 62702
349
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Springfield, IL
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St. Louis, Missouri 63128
397
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St. Louis, MO
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St. Petersburg, Florida 33707
?
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St. Petersburg, FL
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Tacoma, Washington 98405
2012
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Tacoma, WA
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Titusville, Florida 32796
794
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Titusville, FL
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Trumbull, Connecticut 06611
522
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Trumbull, CT
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Tucson, Arizona 85704
1638
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Tucson, AZ
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Vestavia, Alabama 35209
?
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Vestavia, AL
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Walnut Creek, California 94598
2084
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Walnut Creek, CA
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West Palm Beach, Florida 33409
931
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West Palm Beach, FL
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