Back to resultsComparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
insulin detemir
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes Current intensified insulin treatment Injection of insulin Semilente®MC at bedtime for at least 6 weeks BMI maximum 32 kg/m^2 HbA1c > 5.5 % and < 12.0 % Exclusion Criteria: Current treatment with premixed insulin(s) Impaired hepatic or renal function Recurrent major hypoglycaemia
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Fasting plasma glucose
Secondary Outcome Measures
Adverse events
HbA1c results at the end of each treatment period
Blood glucose
Standard Laboratory Safety Parameters
Hypoglycaemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00184639
Brief Title
Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes
Official Title
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 16, 2004 (Actual)
Primary Completion Date
November 22, 2005 (Actual)
Study Completion Date
November 22, 2005 (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.
A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years 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 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Primary Outcome Measure Information:
Title
Fasting plasma glucose
Time Frame
after 16 and 32 weeks, respectively
Secondary Outcome Measure Information:
Title
Adverse events
Title
HbA1c results at the end of each treatment period
Title
Blood glucose
Title
Standard Laboratory Safety Parameters
Title
Hypoglycaemia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes
Current intensified insulin treatment
Injection of insulin Semilente®MC at bedtime for at least 6 weeks
BMI maximum 32 kg/m^2
HbA1c > 5.5 % and < 12.0 %
Exclusion Criteria:
Current treatment with premixed insulin(s)
Impaired hepatic or renal function
Recurrent major hypoglycaemia
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:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes
We'll reach out to this number within 24 hrs