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C-Peptide Replacement Improves Early Diabetic Neuropathy

Posted: Thursday, January 25, 2007

C-peptide improves sensory nerve function in type 1 diabetic patients with early-stage diabetic neuropathy.

Dr. Karin Ekberg from the Karolinska Institute, Stockholm, Sweden stated that, "In contrast to what was previously the prevailing view, C-peptide is in fact a bioactive peptide and its effect may well be of importance for the maintenance of microvascular function." "Thus, C-peptide deficient patients, i.e., type 1 diabetes patients, should receive replacement of C-peptide probably already from the onset of the disease."

Dr. Ekberg and colleagues examined whether 6 months of treatment with C-peptide improved sensory nerve conduction velocity and other early signs of diabetic neuropathy in the lower extremities of 139 type 1 diabetic patients. They were randomized to low-dose C-peptide at 1.5 mg per day in four divided subcutaneous doses, to a 3-times higher dose, or placebo
At baseline, both sensory and motor nerve conduction velocities were significantly reduced compared with normal, the results indicate.

After 6 months of treatment, peak sensory nerve conduction velocities improved in the groups treated with low-dose or high-dose C-peptide, but not significantly compared with the control group, the researchers report.

However, significantly more patients treated with C-peptide (37%) than patients in the control group (19%) experienced a peak sensory nerve conduction velocity improvement of at least 1 meter/second, the investigators found.

Among patients with the least affected nerve conduction velocity at baseline, improvements in sensory nerve conduction velocity were significantly better among those treated with C-peptide, the researchers say.

Vibration perception threshold and neuropathy impairment assessment also improved in the C-peptide treatment group compared with the placebo group, but motor conduction velocities decreased in both groups during the study.

"C-peptide may be beneficial not only for nerve function, but also for the treatment and prevention of other diabetes-induced long-term complications of type 1 diabetes," Dr. Ekberg said. "There are clinical and pre-clinical data to indicate that C-peptide administration serves to ameliorate both functional and structural abnormalities in type 1 diabetic nephropathy."

The group plans "to continue the pharmaceutical development of C-peptide with phase III clinical studies in order to demonstrate the safety and efficacy of C-peptide replacement therapy for the treatment of diabetic peripheral neuropathy," Dr. Ekberg added. "Such studies will include a larger patient population and a treatment duration of at least 12 months."

Source: Diabetes In Control: Diabetes Care 2007;30:71-76