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
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Alhambra, California 91801
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Carlisle, Arkansas 72024
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Charleston, West Virginia 25302
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Charlotte, North Carolina 28277
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Chattanooga, Tennessee 37404
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Chicago, Illinois 60612
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Chicago, IL
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Corpus Christi, Texas 78404
687
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Dallas, Texas 75231
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Duluth, Minnesota 55805
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Durham, North Carolina 27705
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Edmonds, Washington 98026
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Jacksonville, Florida 32207
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Jonesboro, Arkansas 72401
415
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Melbourne, Florida 32901
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Miami, Florida 33136
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Mission Viejo, California 92691
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North Plainfield, New Jersey 07060
1264
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Ocala, Florida 34471
1080
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Oklahoma City, Oklahoma 73112
158
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Pembroke Pines, Florida 33026
1309
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Renton, Washington 98057
1402
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Richmond, Virginia 23219
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Salt Lake City, Utah 84132
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San Antonio, Texas 78224
576
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Springfield, Illinois 62702
464
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St. Louis, Missouri 63128
415
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St. Petersburg, Florida 33707
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Tacoma, Washington 98405
1407
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Titusville, Florida 32796
1166
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Trumbull, Connecticut 06611
1329
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Tucson, Arizona 85704
832
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Vestavia, Alabama 35209
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Walnut Creek, California 94598
1318
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West Palm Beach, Florida 33409
1284
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Worcester, Massachusetts 01655
1405
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