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Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
This study has been completed.
First Received: August 30, 2005   Last Updated: January 29, 2009   History of Changes
Sponsor: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141492
  Purpose

This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.


Condition Intervention Phase
Type 2 Diabetes
Hypogonadism
 Drug: Androgel (testosterone gel)
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double Blind, Randomized, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Androgel, as an Adjunct to Hypoglycemic Therapy, in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate
U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to read and write
  2. Males
  3. Between 30-80 years old
  4. Have type 2 diabetes
  5. Diagnoses of hypogonadism or low testosterone

Exclusion Criteria:

  1. On insulin monotherapy
  2. Use of testosterone therapy within the last 6 months
  3. Male breast cancer
  4. History of prostate cancer
  5. History of clinically significant sleep apnea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141492

  Hide Study Locations
Locations
United States, Alabama
Site 54
Mobile, Alabama, United States
Site 58
Birmingham, Alabama, United States
Site 67
Calera, Alabama, United States
United States, Arizona
Site 16
Phoenix, Arizona, United States
United States, California
Site 23
Concord, California, United States
Site 8
Los Gatos, California, United States
Site 12
Mission Viejo, California, United States
Site 1
Torrance, California, United States
Site 35
Anaheim, California, United States
Site 55
La Jolla, California, United States
United States, Connecticut
Site 25
Glastonbury, Connecticut, United States
United States, Florida
Site 13
Ft. Lauderdale, Florida, United States
Site 21
West Palm Beach, Florida, United States
Site 27
Tampa, Florida, United States
Site 33
Ocala, Florida, United States
Site 43
Jacksonville, Florida, United States
United States, Georgia
Site 7
Atlanta, Georgia, United States
Site 26
Columbus, Georgia, United States
United States, Idaho
Site 29
Boise, Idaho, United States
Site 45
Idaho Falls, Idaho, United States
United States, Illinois
Site 51
Chicago, Illinois, United States
United States, Iowa
Site 32
Des Moines, Iowa, United States
United States, Louisiana
Site 5
Baton Rouge, Louisiana, United States
United States, Maryland
Site 70
Baltimore, Maryland, United States
United States, Massachusetts
Site 9
Springfield, Massachusetts, United States
Site 48
Watertown, Massachusetts, United States
United States, Michigan
Site 19
Detroit, Michigan, United States
Site 61
Livonia, Michigan, United States
United States, Mississippi
Site 40
Tupelo, Mississippi, United States
United States, Missouri
Site 15
Kansas City, Missouri, United States
Site 65
Chesterfield, Missouri, United States
United States, Nebraska
Site 41
Omaha, Nebraska, United States
United States, Nevada
Site 34
Las Vegas, Nevada, United States
United States, New Jersey
Site 24
Jersey City, New Jersey, United States
United States, New York
Site 49
Buffalo, New York, United States
Site 71
New York, New York, United States
United States, North Carolina
Site 28
Morehead City, North Carolina, United States
Site 44
Fayetteville, North Carolina, United States
Site 60
Morehead City, North Carolina, United States
United States, Oregon
Site 3
Portland, Oregon, United States
Site 31
Portland, Oregon, United States
United States, Pennsylvania
Site 4
Bala Cynwyd, Pennsylvania, United States
Site 38
Lansdale, Pennsylvania, United States
Site 46
Shippensburg, Pennsylvania, United States
Site 64
Carlisle, Pennsylvania, United States
Site 68
Altoona, Pennsylvania, United States
United States, South Carolina
Site 14
Greer, South Carolina, United States
United States, Texas
Site 2
Houston, Texas, United States
Site 6
Humble, Texas, United States
Site 20
Arlington, Texas, United States
Site 11
Dallas, Texas, United States
Site 18
Houston, Texas, United States
Site 10
Houston, Texas, United States
Site 30
La Porte, Texas, United States
Site 36
Houston, Texas, United States
Site 37
San Antonio, Texas, United States
Site 39
Houston, Texas, United States
Site 42
Houston, Texas, United States
Site 57
Sugarland, Texas, United States
Site 53
Houston, Texas, United States
Site 56
Sugarland, Texas, United States
Site 47
Houston, Texas, United States
Site 62
Houston, Texas, United States
Site 63
Houston, Texas, United States
Site 66
Midland, Texas, United States
Site 69
Houston, Texas, United States
United States, Utah
Site 17
Salt Lake City, Utah, United States
Site 52
Ogden, Utah, United States
United States, Virginia
Site 22
Salem, Virginia, United States
United States, Washington
Site 50
Seattle, Washington, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: S176.2.101
Study First Received: August 30, 2005
Last Updated: January 29, 2009
ClinicalTrials.gov Identifier: NCT00141492     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Type 2 diabetes
hypogonadism
testosterone
glycosylated hemoglobin A1C

Additional relevant MeSH terms:
Metabolic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Diabetes Mellitus
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones
 Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Androgens

ClinicalTrials.gov processed this record on November 25, 2009



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