Type 2 Diabetes Clinical Trial
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
| Verified date | January 2009 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | June 2007 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 30 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 68 | Altoona | Pennsylvania |
| United States | Site 35 | Anaheim | California |
| United States | Site 20 | Arlington | Texas |
| United States | Site 7 | Atlanta | Georgia |
| United States | Site 4 | Bala Cynwyd | Pennsylvania |
| United States | Site 70 | Baltimore | Maryland |
| United States | Site 5 | Baton Rouge | Louisiana |
| United States | Site 58 | Birmingham | Alabama |
| United States | Site 29 | Boise | Idaho |
| United States | Site 49 | Buffalo | New York |
| United States | Site 67 | Calera | Alabama |
| United States | Site 64 | Carlisle | Pennsylvania |
| United States | Site 65 | Chesterfield | Missouri |
| United States | Site 51 | Chicago | Illinois |
| United States | Site 26 | Columbus | Georgia |
| United States | Site 23 | Concord | California |
| United States | Site 11 | Dallas | Texas |
| United States | Site 32 | Des Moines | Iowa |
| United States | Site 19 | Detroit | Michigan |
| United States | Site 44 | Fayetteville | North Carolina |
| United States | Site 13 | Ft. Lauderdale | Florida |
| United States | Site 25 | Glastonbury | Connecticut |
| United States | Site 14 | Greer | South Carolina |
| United States | Site 10 | Houston | Texas |
| United States | Site 18 | Houston | Texas |
| United States | Site 2 | Houston | Texas |
| United States | Site 36 | Houston | Texas |
| United States | Site 39 | Houston | Texas |
| United States | Site 42 | Houston | Texas |
| United States | Site 47 | Houston | Texas |
| United States | Site 53 | Houston | Texas |
| United States | Site 62 | Houston | Texas |
| United States | Site 63 | Houston | Texas |
| United States | Site 69 | Houston | Texas |
| United States | Site 6 | Humble | Texas |
| United States | Site 45 | Idaho Falls | Idaho |
| United States | Site 43 | Jacksonville | Florida |
| United States | Site 24 | Jersey City | New Jersey |
| United States | Site 15 | Kansas City | Missouri |
| United States | Site 55 | La Jolla | California |
| United States | Site 30 | La Porte | Texas |
| United States | Site 38 | Lansdale | Pennsylvania |
| United States | Site 34 | Las Vegas | Nevada |
| United States | Site 61 | Livonia | Michigan |
| United States | Site 8 | Los Gatos | California |
| United States | Site 66 | Midland | Texas |
| United States | Site 12 | Mission Viejo | California |
| United States | Site 54 | Mobile | Alabama |
| United States | Site 28 | Morehead City | North Carolina |
| United States | Site 60 | Morehead City | North Carolina |
| United States | Site 71 | New York | New York |
| United States | Site 33 | Ocala | Florida |
| United States | Site 52 | Ogden | Utah |
| United States | Site 41 | Omaha | Nebraska |
| United States | Site 16 | Phoenix | Arizona |
| United States | Site 3 | Portland | Oregon |
| United States | Site 31 | Portland | Oregon |
| United States | Site 22 | Salem | Virginia |
| United States | Site 17 | Salt Lake City | Utah |
| United States | Site 37 | San Antonio | Texas |
| United States | Site 50 | Seattle | Washington |
| United States | Site 46 | Shippensburg | Pennsylvania |
| United States | Site 9 | Springfield | Massachusetts |
| United States | Site 56 | Sugarland | Texas |
| United States | Site 57 | Sugarland | Texas |
| United States | Site 27 | Tampa | Florida |
| United States | Site 1 | Torrance | California |
| United States | Site 40 | Tupelo | Mississippi |
| United States | Site 48 | Watertown | Massachusetts |
| United States | Site 21 | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States,
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