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Effects of Shifting From Twice Daily Insulin Glargine or Detemir to Once Daily Insulin Degludec in Type 1 Diabetes

NCT02360254 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2016-08-16

No results posted yet for this study

Summary

Rationale. Degludec is a longer-acting insulin analog compared to glargine and detemir. In a fraction of type 1 diabetic patients, insulin glargine and insulin detemir may not achieve 24h coverage, reflected by raising pre-dinner glucose levels when they are administered at bedtime. As up-titration of bedtime long acting insulin increases risk of nocturnal hypoglycaemia, this clinical problem can be addressed by an additional injection of in the morning. These type 1 diabetic patients may benefit from shifting from twice daily insulin glargine/detemir to once daily insulin degludec, which shows an extended activity over 24h, up to 48h.

Objective. To evaluate the effects of shifting from twice daily insulin glargine or detemir to once daily insulin degludec on HbA1c and glucose profiles in type 1 diabetic patients during a period of 3 months.

Study design. Observational analytic prospective study. Protocol. Type 1 diabetic patients on twice daily insulin glargine or detemir (because of pre-dinner hyperglycemia due to supposed glargine/detemir coverage \<24h) will be identified and enrolled. During a run-in period of 1 week, the investigators will collect data on HbA1c values as IFCC/DCCT-aligned and on glucose profiles using glucose meters. Patients will undergo a 7-14 day continuous glucose monitoring before and eventually during (additional 7-14 days) the shift from twice to once daily basal insulin. Patients will be re-assessed 12 weeks after initiation of insulin degludec with determination of HbA1c and 7-14 day continuous glucose monitoring.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin degludec

Once daily injection of insulin degludec

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • University of Padova

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31
Completion
2016-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360254 on ClinicalTrials.gov