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C-Peptide Replacement Therapy and Sensory Nerve Function in Type 1 Diabetic Neuropathy

¹ Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
² Clinical Neuroscience, Section of Clinical Neurophysiology, Karolinska Institutet, Stockholm, Sweden
³ Section of Neurology, Karolinska Institutet, Stockholm, Sweden
⁴ Medicine at Lundby Hospital, Gothenburg, Sweden
⁵ Section of Medicine, Uppsala University Hospital, Uppsala, Sweden
⁶ Section of Medicine, Linköping University Hospital, Linköping, Sweden
⁷ Section of Medicine, Karolinska Institutet, Stockholm, Sweden

Address correspondence and reprint requests to Karin Ekberg, PhD, Creative Peptides, Fogdevreten 2, SE-171 77 Stockholm, Sweden. E-mail: karin.ekberg{at}creativepeptides.se

OBJECTIVE—C-peptide replacement in animals results in amelioration of diabetes-induced functional and structural abnormalities in peripheral nerves. The present study was undertaken to examine whether C-peptide administration to patients with type 1 diabetes and peripheral neuropathy improves sensory nerve function.

RESEARCH DESIGN AND METHODS—This was an exploratory, double-blinded, randomized, and placebo-controlled study with three study groups that was carried out at five centers in Sweden. C-peptide was given as a replacement dose (1.5 mg/day, divided into four subcutaneous doses) or a dose three times higher (4.5 mg/day) during 6 months. Neurological examination and neurophysiological measurements were performed before and after 6 months of treatment with C-peptide or placebo.

RESULTS—The age of the 139 patients who completed the protocol was 44.2 ± 0.6 (mean ± SE) years and their duration of diabetes was 30.6 ± 0.8 years. Clinical neurological impairment (NIA) (score >7 points) of the lower extremities was present in 86% of the patients at baseline. Sensory nerve conduction velocity (SCV) was 2.6 ± 0.08 SD below body height–corrected normal values at baseline and improved similarly within the two C-peptide groups (P < 0.007). The number of patients responding with a SCV peak potential improvement >1.0 m/s was greater in C-peptide–treated patients than in those receiving placebo (P < 0.03). In the least severely affected patients (SCV < 2.5 SD below normal at baseline, n = 70) SCV improved by 1.0 m/s (P < 0.014 vs. placebo). NIA score and vibration perception both improved within the C-peptide–treated groups (P < 0.011 and P < 0.002). A1C levels (7.6 ± 0.1% at baseline) decreased slightly but similarly in C-peptide–and placebo-treated patients during the study.

CONCLUSIONS—C-peptide treatment for 6 months improves sensory nerve function in early-stage type 1 diabetic neuropathy.

Abbreviations: CMAP, compound muscle action potential amplitude • MCV, motor nerve conduction velocity • NIA, neuropathy impairment assessment • QST, quantitative sensory testing • SCV, sensory nerve conduction velocity • SCVi, sensory nerve conduction velocity measured at initial potential deflection • SCVp, sensory nerve conduction velocity measured at peak potential • VPT, vibration perception threshold

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