Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Secondary Hypogonadism

In brief

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

Key facts

Study ID

NCT01191320

Run by

Repros Therapeutics Inc.

People needed

102

Starts

2010-10-01

Expected to finish

2011-12-01

Last updated by the study team

2014-07-24

Who can join

Age: 20 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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.

Where it is running

• Paradigm Clinical Research — Garden Grove, California, United States
• Northern California Research Corp — Sacramento, California, United States
• LABioMed — Torrance, California, United States
• Lahey Clinic — Peabody, Massachusetts, United States
• Affiliated Clinical Research — Las Vegas, Nevada, United States
• Affiliated Clinical Research — Las Vegas, Nevada, United States
• Dr. Bruce Gilbert — Great Neck, New York, United States
• University Urology — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Dr. Michael Werner — Purchase, New York, United States
• Discovery Clinical Trials — Austin, Texas, United States
• Research Across America — Carrollton, Texas, United States
• TX Urology Associate — Houston, Texas, United States
• Centex Research — Houston, Texas, United States
• Dr. Rakesh Patel — Houston, Texas, United States
• Protenium Clinical Research — Hurst, Texas, United States
• R/D Clinical Research — Lake Jackson, Texas, United States
• Cetero Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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