NCT00313742

Brief Summary

This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4 diabetes

Geographic Reach
2 countries

2 active sites

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

April 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

April 11, 2006

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise

    following 4 weeks of treatment

Secondary Outcomes (4)

  • Plasma glucose pre-exercise & post-exercise

  • Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning

  • Plasma glucose profile post-exercise

  • Incidence of adverse events during the trial

Interventions

insulin detemirDRUG
insulin glargineDRUG
insulin NPHDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 Diabetes
  • Current basal-bolus insulin therapy
  • HbA1c \< 10%
  • BMI \< 32 kg/m2

You may not qualify if:

  • Proliferative Retinopathy / Maculopathy
  • Recurrent major hypoglycaemias
  • Impaired hepatic or renal function
  • Cardiac Problems
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Neuss, 41460, Germany

Location

Unknown Facility

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin DetemirInsulin GlargineInsulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

DE(1)GB(1)