NCT02360254

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

January 30, 2015

Last Update Submit

August 14, 2016

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    Change in HbA1c from baseline to 12 weeks after enrollment

    12 weeks

Secondary Outcomes (4)

  • Fasting plasma glucose

    12 weeks

  • Time spent in hyperglycemia

    12 weeks

  • Time spent in hypoglycemia

    12 weeks

  • Glucose variability

    12 weeks

Study Arms (2)

Patients shifting to insulin degludec

Patients shifting from twice daily glargine or detemir to once daily degludec. This change in therapy will have to be decided by the diabetologist and the patient, not done for the purpose of the study.

Drug: Insulin degludec

Patients remaining on twice daily glargine/detemir

Patients continuing on twice daily glargine or detemir

Interventions

Insulin degludecDRUG

Once daily injection of insulin degludec

Also known as: Tresiba
Patients shifting to insulin degludec

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 1 diabetic patients

You may qualify if:

  • Age 18-65
  • Males or females
  • type 1 diabetes
  • a plan to shift from twice daily glargine or detemir to once daily degludec
  • HbA1c \>=7.0%
  • Informed consent

You may not qualify if:

  • Age \<18 or \>65
  • HbA1c \<7.0%
  • Pregnancy or lactation
  • Recent (within 3 months) acute diseases or surgery
  • Cancer
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Metabolic Diseases, University Hospital of Padova

Padua, 35128, Italy

Location

Related Publications (1)

  • Galasso S, Facchinetti A, Bonora BM, Mariano V, Boscari F, Cipponeri E, Maran A, Avogaro A, Fadini GP, Bruttomesso D. Switching from twice-daily glargine or detemir to once-daily degludec improves glucose control in type 1 diabetes. An observational study. Nutr Metab Cardiovasc Dis. 2016 Dec;26(12):1112-1119. doi: 10.1016/j.numecd.2016.08.002. Epub 2016 Aug 6.

    PMID: 27618501DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 10, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

IT(1)