Back to resultsEfficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Duration of diabetes mellitus for at least 2 years
- Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
- HbA1C below 11.0%
Exclusion Criteria:
- Impaired renal function
- Impaired hepatic function
- Serious heart diseases
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- Proliferative retinopathy or maculopathy requiring acute treatment
- Uncontrolled treated/untreated hypertension
- Current treatment with total insulin dose of more than 100 IU/day
- Current treatment or expected at the screening to start treatment with systemic corticosteroids
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
Blood glucose profiles
Hypoglycaemic episodes
Adverse events
Body weight
Insulin antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00604344
Brief Title
Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes
Official Title
A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 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 Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 48 weeks of treatment
Secondary Outcome Measure Information:
Title
Blood glucose profiles
Title
Hypoglycaemic episodes
Title
Adverse events
Title
Body weight
Title
Insulin antibodies
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Duration of diabetes mellitus for at least 2 years
Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
HbA1C below 11.0%
Exclusion Criteria:
Impaired renal function
Impaired hepatic function
Serious heart diseases
Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Proliferative retinopathy or maculopathy requiring acute treatment
Uncontrolled treated/untreated hypertension
Current treatment with total insulin dose of more than 100 IU/day
Current treatment or expected at the screening to start treatment with systemic corticosteroids
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
Tokyo
ZIP/Postal Code
1000005
Country
Japan
12. IPD Sharing Statement
Citations:
Citation
Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 48-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Subjects with Insulin Requriring Diabetes Mellitus in a Basal-bolus Regimen. J. Japan Diab. Soc 2007; 50 (9): 649-663
Results Reference
result
Citation
Kobayashi M, Iwamoto Y, Kawamori R, Tajima N, Nishida T, Kaku K. Insulin detemir achieves lower, less variable fasting glucose and a reduced risk of nocturnal hypoglycaemia and weight gain compared to NPH insulin in basal bolus therapy of Japanese patients with type 1 diabetes. Diabetologia 2006; 49 (Suppl 1): A608-A609 [Abstract 995]
Results Reference
result
Citation
Ishii H, Iwamoto Y, Kaku K, Kawamori R, Tajima N, Kobayashi M. Quality of Life (QoL) Assessment of Insulin Detemir and NPH Human Insulin in Japanese Subjects with Diabetes on Basal-Bolus Regimen. Diabetes 2007; 56 (Suppl. 1): A170 (2805-PO)
Results Reference
result
PubMed Identifier
33166419
Citation
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes
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