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Sponsored by: |
Creative Peptides Sweden Inc. |
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Information provided by: | Creative Peptides Sweden Inc. |
ClinicalTrials.gov Identifier: | NCT00278980 |
The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 Diabetic Polyneuropathy |
Drug: C-peptide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups |
Estimated Enrollment: | 180 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | December 2004 |
It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Karolinska University Hospital Solna | |
Stockholm, Sweden, SE-171 76 |
Principal Investigator: | Lisa Juntti-Berggren, MD, PhD | Karolinska University Hospital Solna, Stockholm, Sweden |
Study ID Numbers: | CPSp201 |
Study First Received: | January 12, 2006 |
Last Updated: | January 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00278980 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
Metabolic Diseases Autoimmune Diseases Diabetic Neuropathies Polyneuropathies Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 Signs and Symptoms |
Diabetes Mellitus, Type 1 Neuromuscular Diseases Peripheral Nervous System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Diabetes Complications |
Metabolic Diseases Autoimmune Diseases Diabetic Neuropathies Immune System Diseases Nervous System Diseases Diabetes Mellitus Polyneuropathies |
Endocrine System Diseases Diabetes Mellitus, Type 1 Neuromuscular Diseases Peripheral Nervous System Diseases Glucose Metabolism Disorders Diabetes Complications |