None listed
Conditions
Brief summary
This pilot study was designed to assess whether treatment with GC811007 would arrest the decline in renal function and the associated progression of diabetic retinopathy, peripheral neuropathy and autonomic neuropathy in patients with Type 2 diabetes mellitus. The safety and tolerability of GC811007 also were assessed.
Interventions
This was a randomized, double-blind, Placebo-controlled study in adult patients with diabetic nephropathy. Upon completion of screening, Enrolment and a 3-week Placebo-run-in period, patients were randomized to treatment with 1200 mg/day, GC811007 (taken as two 300-mg capsules twice daily, BID, before meals) or Placebo, administered as 2 identical 300-mg capsules taken orally twice daily (BID) before meals for 6 months. Patients underwent safety and efficacy assessments during clinic visits at M
This was a randomized, double-blind, Placebo-controlled study in adult patients with diabetic nephropathy. Upon completion of screening, Enrolment and a 3-week Placebo-run-in period, patients were randomized to treatment with 1200 mg/day, GC811007 (taken as two 300-mg capsules twice daily, BID, before meals) or Placebo, administered as 2 identical 300-mg capsules taken orally twice daily (BID) before meals for 6 months. Patients underwent safety and efficacy assessments during clinic visits at Months 0, 2, 4, and 6. Telephone follow-up interviews were conducted 2 weeks after the final clinic visit.
Sponsors
Protemix Corporation, Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Men and women between 30 to 70 years of age with poor blood glucose control, retinopathy and nephropathy resulting from Type 2 diabetes mellitus.
Exclusion criteria
Healthy volunteers excluded, and those with with poor blood glucose control, retinopathy and nephropathy resulting from Type 2 diabetes mellitus, but outside of the age range above
Outcome results
None listed