A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy

This study is a double-blind, placebo controlled study with three phases;

• a pre-study medication washout/screening phase upto 3 weeks
• a 3-week, open label phase
• a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria.

Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.

Inclusion criteria

• 18 years or older
• Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
• At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
• HbA1c < 12 % at Screening
• Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
• Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.
• Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or,
• If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1.

Exclusion criteria

• Pregnant or lactating females
• Subjects with BMI over 40
• Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
• Subjects with known clinically significant decreased blood flow to the extremities
• Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
• Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
• Have profound autonomic dysfunction, or brittle diabetes;
• Evidence of amputations (including toes), open ulcers, or Charcot joint.