NCT00278980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
Last Updated

January 19, 2006

Status Verified

January 1, 2006

First QC Date

January 12, 2006

Last Update Submit

January 12, 2006

Conditions

Diabetes Mellitus, Type 1Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (1)

  • Change in sensory nerve conduction velocity from baseline to 6 mo of treatment

Secondary Outcomes (3)

  • - Change in quantitative sensory tests and

  • neurological impairment assessment from baseline to 6 mo of treatment

  • - Safety and tolerability of C-peptide

Interventions

C-peptideDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who have a duration of type 1 diabetes of more than 5 yrs
  • Subjects who are C-peptide deficient
  • Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
  • Subjects who have measurable action potential in the sural nerves
  • Subjects who have reduced nerve conduction velocity in the sural nerves

You may not qualify if:

  • Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
  • Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
  • Subjects who are transplanted (islet cell, kidney or pancreas)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital Solna

Stockholm, Stockholm County, SE-171 76, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic Neuropathies

Interventions

C-Peptide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Lisa Juntti-Berggren, MD, PhD

    Karolinska University Hospital Solna, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 19, 2006

Study Start

October 1, 2003

Study Completion

December 1, 2004

Last Updated

January 19, 2006

Record last verified: 2006-01

Locations

SE(1)