A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics
A Trial Assessing the Number of Hypoglycaemic Episodes and Glycaemic Variability During Two Different Regimens of SIBA 200 U/ml in Subjects With Type 1 Diabetes
2 other identifiers
interventional
18
1 country
1
Brief Summary
This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Aug 2009
Shorter than P25 for phase_1 diabetes
1 active site
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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedNovember 27, 2013
November 1, 2013
1 month
August 24, 2009
November 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Total number of periods where carbohydrate supplementation is needed during the treatment
Assessed every day of the two in-house stays of nine days
Secondary Outcomes (2)
Frequency of adverse events (AEs)
Assessed every day of the two in-house stays of nine days and one follow-up by telephone
Number of periods with low blood sugar during treatment
Assessed every day of the two in-house stays of nine days and one follow-up by telephone
Study Arms (2)
SIBA 3W
EXPERIMENTALSIBA OD
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus for at least 12 months
- Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)
You may not qualify if:
- Donation or loss of more than 500 ml blood or plasma within three months prior to this trial
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods
- Prior or current treatment with metformin or thiazolidinediones
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Neuss, 41460, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 25, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 27, 2013
Record last verified: 2013-11