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Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Duration of type 1 diabetes for at least 12 months
  • BMI below 35 kg/m2
  • HbA1c between 7.0-12.0%
  • Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
  • Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Previous participation in this trial
  • Receipt of any investigational products within the last 2 months prior to this trial
  • Drug or alcohol dependence
  • Pregnancy, breast-feeding or intention of becoming pregnant

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Plasma glucose profiles
Change in body weight
Quality of Life
Incidence of adverse events
Incidence of hypoglycaemic episodes

Full Information

First Posted
January 7, 2008
Last Updated
February 22, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00595374
Brief Title
Efficacy and Safety of Insulin Detemir in Type 1 Diabetes
Official Title
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2, 2003 (Actual)
Primary Completion Date
October 7, 2004 (Actual)
Study Completion Date
October 7, 2004 (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 of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

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
114 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 26 weeks of treatment
Secondary Outcome Measure Information:
Title
Plasma glucose profiles
Title
Change in body weight
Title
Quality of Life
Title
Incidence of adverse events
Title
Incidence of hypoglycaemic episodes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Duration of type 1 diabetes for at least 12 months BMI below 35 kg/m2 HbA1c between 7.0-12.0% Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator Exclusion Criteria: Known or suspected allergy to trial product or related products Previous participation in this trial Receipt of any investigational products within the last 2 months prior to this trial Drug or alcohol dependence Pregnancy, breast-feeding or intention of becoming pregnant
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
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2566 MJ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Helder
ZIP/Postal Code
1782 GZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Deventer
ZIP/Postal Code
7415 CM
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Gouda
ZIP/Postal Code
2805 AH
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Meppel
ZIP/Postal Code
7943 KA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Stadskanaal
ZIP/Postal Code
9501 EH
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Utrecht
ZIP/Postal Code
3563 AZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Waalwijk
ZIP/Postal Code
5141 BM
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Weert
ZIP/Postal Code
6001 BE
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Zevenaar
ZIP/Postal Code
6903 ZN
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

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