Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the
Company has received verbal confirmation from the Division of Metabolic
and Endocrine Drug Products of the Food and Drug Agency that the Company
may initiate its Investigational New Drug Application for the study of
oral Androxal® in the treatment of hypogonadal men with Type
II Diabetes (T2D) with a Phase IIa trial. The FDA noted no clinical hold
issues but added that it may have some comments on the specifics of the
Phase II design. Doses to be tested in the Phase IIa study have been
safely tested for longer durations in trials in men for the treatment of
secondary hypogonadism.
“A Randomized, Parallel,
Double-Blind, Placebo Controlled and Open-Label-Active-Controlled
Exploratory Study to Evaluate the Efficacy of Androxal in Improving
Glycemic Control in Men with Secondary Hypogonadism or Adult-Onset
Idiopathic Hypogonadotrophic Hypogonadism (AIHH) and Type II Diabetes
Mellitus”
The opening Phase IIa study is entitled, “A Randomized, Parallel,
Double-Blind, Placebo Controlled and Open-Label-Active-Controlled
Exploratory Study to Evaluate the Efficacy of Androxal in Improving
Glycemic Control in Men with Secondary Hypogonadism or Adult-Onset
Idiopathic Hypogonadotrophic Hypogonadism (AIHH) and Type II Diabetes
Mellitus”. Repros plans to enroll a total of 60 men into three balanced
parallel arms at several clinical sites comparing placebo to two active
doses. The lead investigator for the study is Glenn R. Cunningham MD,
Professor, Baylor College of Medicine, Division of Diabetes,
Endocrinology & Metabolism, Departments of Medicine & Cellular Biology
and the Medical Director, St. Luke’s Episcopal Hospital – Baylor
Diabetes Program. Dr. Cunningham consulted with Repros in the
development of the protocol.
To be included in the study men, age 20 to 80, must have been previously
diagnosed with T2D mellitus as defined by the American Diabetes
Association criteria for at least 6 months. The men must also have been
receiving a stable dose of an oral hypoglycemic agent (OHA). The men
must have a fasting serum glucose level of greater than 126 mg/dL but
less than or equal to 220 mg/dL and HemoglobinA1c (HbA1c)
between 7% and 9.5% while being treated with their prescribed OHA. The
men must also exhibit a morning testosterone level of less than 300
ng/dL and a serum LH of between 1 and 8 mIU/ml.
Men will be treated for three months. The primary endpoints are the
change in HbA1c from baseline to 3 months as well as the
difference between placebo and the two active arms, the change in
fasting blood glucose from baseline to months 1, 2, and 3 for each
treatment group and the change in total testosterone from baseline to
month 3.
In a 200 patient study of Androxal in hypogonadal men it was noted that
fasting glucose levels were reduced in a significant manner in men whose
glucose levels were greater than 104 mg/dL. It was further noted that
the higher the glucose level the greater the reduction. This effect was
noted in the group of men administered Androxal but not at the same rate
in the placebo or topical testosterone treatment groups. Roughly 20% of
the men in the 200 patient trial were previously diagnosed with diabetes
and were receiving OHAs.