Type 2 DiabetesPhase 2NCT00141492
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
A Phase 2 study testing Androgel (testosterone gel) in people with Type 2 Diabetes and Hypogonadism, run by Solvay Pharmaceuticals at 70 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Type 2 Diabetes, Hypogonadism
- What is being tested?
- Androgel (testosterone gel)
- How many people
- Not given
- Where
- 70 sitesUnited States
- Study dates
- Oct 2004to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read and write
- Males
- Between 30-80 years old
- Have type 2 diabetes
- Diagnoses of hypogonadism or low testosterone
Who cannot join
- On insulin monotherapy
- Use of testosterone therapy within the last 6 months
- Male breast cancer
- History of prostate cancer
- History of clinically significant sleep apnea
Trial locations and contacts
70 sites in 1 country.
70 sites in 1 country
United States70 sites
Site 68
Altoona, Pennsylvania
Site 35
Anaheim, California
Site 20
Arlington, Texas
Site 7
Atlanta, Georgia
Site 4
Bala-Cynwyd, Pennsylvania
Site 70
Baltimore, Maryland
Site 5
Baton Rouge, Louisiana
Site 58
Birmingham, Alabama
Site 29
Boise, Idaho
Site 49
Buffalo, New York
Site 67
Calera, Alabama
Site 64
Carlisle, Pennsylvania
Site 65
Chesterfield, Missouri
Site 51
Chicago, Illinois
Site 26
Columbus, Georgia
Site 23
Concord, California
Site 11
Dallas, Texas
Site 32
Des Moines, Iowa
Site 19
Detroit, Michigan
Site 44
Fayetteville, North Carolina
Site 13
Fort Lauderdale, Florida
Site 25
Glastonbury, Connecticut
Site 14
Greer, South Carolina
Site 10
Houston, Texas
Site 18
Houston, Texas
Site 2
Houston, Texas
Site 36
Houston, Texas
Site 39
Houston, Texas
Site 42
Houston, Texas
Site 47
Houston, Texas
Site 53
Houston, Texas
Site 62
Houston, Texas
Site 63
Houston, Texas
Site 69
Houston, Texas
Site 6
Humble, Texas
Site 45
Idaho Falls, Idaho
Site 43
Jacksonville, Florida
Site 24
Jersey City, New Jersey
Site 15
Kansas City, Missouri
Site 55
La Jolla, California
Site 30
La Porte, Texas
Site 38
Lansdale, Pennsylvania
Site 34
Las Vegas, Nevada
Site 61
Livonia, Michigan
Site 8
Los Gatos, California
Site 66
Midland, Texas
Site 12
Mission Viejo, California
Site 54
Mobile, Alabama
Site 28
Morehead City, North Carolina
Site 60
Morehead City, North Carolina
Site 71
New York, New York
Site 33
Ocala, Florida
Site 52
Ogden, Utah
Site 41
Omaha, Nebraska
Site 16
Phoenix, Arizona
Site 31
Portland, Oregon
Site 3
Portland, Oregon
Site 22
Salem, Virginia
Site 17
Salt Lake City, Utah
Site 37
San Antonio, Texas
Site 50
Seattle, Washington
Site 46
Shippensburg, Pennsylvania
Site 9
Springfield, Massachusetts
Site 56
Sugarland, Texas
Site 57
Sugarland, Texas
Site 27
Tampa, Florida
Site 1
Torrance, California
Site 40
Tupelo, Mississippi
Site 48
Watertown, Massachusetts
Site 21
West Palm Beach, Florida
About this 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
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.
- Conditions
- Type 2 Diabetes, Hypogonadism
- Being tested
- Androgel (testosterone gel)
- Keywords
- Type 2 diabetes, hypogonadism, testosterone, glycosylated hemoglobin A1C
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgel (testosterone gel)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141492
- Sponsor's protocol ID
- S176.2.101
- Status last verified
- Jan 2009
- First submitted
- 30 Aug 2005
- Last updated
- 21 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00141492
- Acronym / sponsor ID
- S176.2.101
- Conditions
- Type 2 Diabetes, Hypogonadism
- Keywords
- Type 2 diabetes, hypogonadism, testosterone, glycosylated hemoglobin A1C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to read and write
- Males
- Between 30-80 years old
- Have type 2 diabetes
- Diagnoses of hypogonadism or low testosterone
Key exclusion criteria (5 listed)
- On insulin monotherapy
- Use of testosterone therapy within the last 6 months
- Male breast cancer
- History of prostate cancer
- History of clinically significant sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgel (testosterone gel) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgel (testosterone gel) in people with Type 2 Diabetes and Hypogonadism, run by Solvay Pharmaceuticals at 70 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.