Back to resultsA 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
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec
insulin degludec
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus for at least 12 months
- Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SIBA 3W
SIBA OD
Arm Description
Outcomes
Primary Outcome Measures
Total number of periods where carbohydrate supplementation is needed during the treatment
Secondary Outcome Measures
Frequency of adverse events (AEs)
Number of periods with low blood sugar during treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00964964
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIBA 3W
Arm Type
Experimental
Arm Title
SIBA OD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Insulin degludec injected s.c. (under the skin) three times weekly
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Insulin degludec injected s.c. (under the skin) once daily for one week
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo injected s.c. (under the skin) four times weekly
Primary Outcome Measure Information:
Title
Total number of periods where carbohydrate supplementation is needed during the treatment
Time Frame
Assessed every day of the two in-house stays of nine days
Secondary Outcome Measure Information:
Title
Frequency of adverse events (AEs)
Time Frame
Assessed every day of the two in-house stays of nine days and one follow-up by telephone
Title
Number of periods with low blood sugar during treatment
Time Frame
Assessed every day of the two in-house stays of nine days and one follow-up by telephone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus for at least 12 months
Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
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
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