Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabet… (NCT01191320) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
United States102 participantsStarted 2010-10
Plain-language 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
Who can participate
Age range20 Years – 80 Years
SexMALE
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Inclusion Criteria:
* 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
Exclusion Criteria:
* A history of testicular failure, Kallmann Syndrome or other infertility condition
* Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary,…