Type 2 Diabetes MellitusPhase 2NCT01191320
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
A Phase 2 study testing Androxal in people with Type 2 Diabetes Mellitus and Secondary Hypogonadism, run by Repros Therapeutics Inc. at 18 sites in United States.
Trial summary
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Secondary Hypogonadism
- What is being tested?
- Androxal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, ages 20 to 80-years-old, inclusive
- A diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria for at least 6 months
- Treatment with a stable but sub-optimum dose of OHAs for at least 2 months prior to screening based on a lack of control of blood glucose
- Previous diagnosis of adult-onset idiopathic hypogonadotropic hypogonadism (AIHH) and have undergone treatment with a topical testosterone gel, Low-to-borderline morning total testosterone (TT), after at least a two week wash-out period, and normal or low normal serum luteinizing hormone (LH)at screening and at baseline
- No previous diagnosis of AIHH but present as naïve patients with low morning TT and normal or low normal serum LH at screening and at baseline
- Body Mass Index (BMI) between 26 and 40 kg/m2
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- Fasting blood (plasma or serum) glucose (FBG) between 125 and 240 mg/dL
- HemoglobinA1c in serum as (HbA1c) between 7% and 9.5%
- Comprehends informed consent
- Otherwise normal healthy males
- All clinical laboratory test within normal ranges (any deviation outside the normal range will require approval of investigator)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
Who cannot join
- A history of testicular failure, Kallmann Syndrome or other infertility condition
- Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary, laboratory abnormalities, or having received an investigational drug in the past 30 days prior to study
- Prostate nodules or induration, a history of, known, or suspect prostate cancer not ruled out by a negative biopsy, or a prostate specific antigen (PSA) higher than 3.5;
- Hematocrit in excess of 47% or a hemoglobin (Hb) greater than 16 g/dl
- Previous treatment with androgens, estrogens, DHEA, testosterone or testosterone analogues in injectable, oral, topical or other forms for the treatment of AIHH who have not discontinued at the start of the treatment phase;
- Primary hypogonadism as typified as a serum LH greater than 15 and a TT value less than 300 ng/dL
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- Continuous use of corticosteroids
- History of or current diagnosis of major macrovascular complications of T2DM: myocardial infarction (MI) or stroke within 6 months, or any history of coronary revascularization, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) greater than or equal to 2
- Uncontrolled sitting blood pressure (BP) greater than 150/95, serum creatinine (Cr) greater than 1.5 ULN or estimated glomerular filtration rate (eGFR) less than mL/min/1.73 m2
- Retinopathy requiring continuing ophthalmologic assessments
- Cataracts
- Other significant history of diabetic complications (proteinuria greater than 1 g/d, retinopathy, clear neuropathy)
- Aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than 3 times the upper limits of normal (ULN)
- Total bilirubin greater than 2.0 mg/dL (>34 µmol/L);
- Injectable testosterone within 120 days of Screening (Visit 1)
- Reported substance abuse at screening
- Taking insulin therapy;
- Clinically significant abnormal findings on screening examination as determined by the investigator
- Known hypersensitivity to clomiphene citrate;
- Current or history of breast cancer
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with the study instructions, possibly confound interpretation of the study results, or endanger the participant if he took part in the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Discovery Clinical Trials
Austin, Texas, 78758
Research Across America
Carrollton, Texas, 75010
Paradigm Clinical Research
Garden Grove, California, 92844
Dr. Bruce Gilbert
Great Neck, New York, 11021
TX Urology Associate
Houston, Texas, 77024
Centex Research
Houston, Texas, 77062
Dr. Rakesh Patel
Houston, Texas, 77095
Protenium Clinical Research
Hurst, Texas, 76054
R/D Clinical Research
Lake Jackson, Texas, 77566
Affiliated Clinical Research
Las Vegas, Nevada, 89109
Affiliated Clinical Research
Las Vegas, Nevada, 89144
University Urology
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Lahey Clinic
Peabody, Massachusetts, 01960
Dr. Michael Werner
Purchase, New York, 10577
Northern California Research Corp
Sacramento, California, 95821
Cetero Research
San Antonio, Texas, 78229
LABioMed
Torrance, California, 90502
About this study
Official title: A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
Read the detailed description
A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit.
- Conditions
- Type 2 Diabetes Mellitus, Secondary Hypogonadism
- Being tested
- Placebo, Androxal
- Keywords
- Adult onset hypogonadotropic hypogonadism
- 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.
PlaceboDrug
Placebo capsule 1x daily for 3 months
AndroxalDrug
Also called Enclomiphene citrate
Capsules 12.5 mg or 25 mg 1x daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Androxal 12.5 mg | Experimental | 12.5 mg/day Receives: Drug: Androxal |
| Androxal 25 mg | Experimental | 25 mg/day Receives: Drug: Androxal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C
The change in HbA1c from Baseline to 3 Months for each treatment arm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Cunningham, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191320
- Sponsor's protocol ID
- ZA-202
- Status last verified
- Jun 2014
- First submitted
- 27 Aug 2010
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment
- ClinicalTrials.gov ID
- NCT01191320
- Acronym / sponsor ID
- ZA-202
- Conditions
- Type 2 Diabetes Mellitus, Secondary Hypogonadism
- Keywords
- Adult onset hypogonadotropic hypogonadism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Posted 24 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
Detailed description
A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Androxal 12.5 mg | Experimental | Drug: Androxal12.5 mg/day |
| Androxal 25 mg | Experimental | Drug: Androxal25 mg/day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males, ages 20 to 80-years-old, inclusive
- A diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria for at least 6 months
- Treatment with a stable but sub-optimum dose of OHAs for at least 2 months prior to screening based on a lack of control of blood glucose
- Previous diagnosis of adult-onset idiopathic hypogonadotropic hypogonadism (AIHH) and have undergone treatment with a topical testosterone gel, Low-to-borderline morning total testosterone (TT), after at least a two week wash-out period, and normal or low normal serum luteinizing hormone (LH)at screening and at baseline
- No previous diagnosis of AIHH but present as naïve patients with low morning TT and normal or low normal serum LH at screening and at baseline
Key exclusion criteria (21 listed)
- A history of testicular failure, Kallmann Syndrome or other infertility condition
- Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary, laboratory abnormalities, or having received an investigational drug in the past 30 days prior to study
- Prostate nodules or induration, a history of, known, or suspect prostate cancer not ruled out by a negative biopsy, or a prostate specific antigen (PSA) higher than 3.5;
- Hematocrit in excess of 47% or a hemoglobin (Hb) greater than 16 g/dl
- Previous treatment with androgens, estrogens, DHEA, testosterone or testosterone analogues in injectable, oral, topical or other forms for the treatment of AIHH who have not discontinued at the start of the treatment phase;
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 |
|---|---|---|
| PlaceboPlacebo capsule 1x daily for 3 months | Drug | Placebo |
| AndroxalAlso: Enclomiphene citrateCapsules 12.5 mg or 25 mg 1x daily for 3 months | Drug | Androxal 12.5 mg, Androxal 25 mg |
Primary outcome
Change in HbA1C
Time frame: 3 months
The change in HbA1c from Baseline to 3 Months for each treatment arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor websiteLink provided by the sponsor.
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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.
Glenn Cunningham, MD principal investigator
Baylor College of Medicine
18 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 Androxal in people with Type 2 Diabetes Mellitus and Secondary Hypogonadism, run by Repros Therapeutics Inc. at 18 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 13 inclusion and 21 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change in HbA1C (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 24 Jul 2014.