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Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
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: Type 2 diabetes for at least 12 months Currently treated with Oral Antidiabetic Drugs BMI lesser than or equal to 40 kg/m2 HbA1c greater than or equal 7.5 and lesser than or equal to 11% Exclusion Criteria: Proliferative retinopathy or maculopathy Recurrent major hypoglycaemia uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Outcomes

Primary Outcome Measures

HbA1C

Secondary Outcome Measures

Adverse events
body weight
Hypoglycemia
Blood glucose

Full Information

First Posted
February 23, 2005
Last Updated
January 27, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00104182
Brief Title
Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes
Official Title
Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (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 and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
503 (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 20 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Title
body weight
Title
Hypoglycemia
Title
Blood glucose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes for at least 12 months Currently treated with Oral Antidiabetic Drugs BMI lesser than or equal to 40 kg/m2 HbA1c greater than or equal 7.5 and lesser than or equal to 11% Exclusion Criteria: Proliferative retinopathy or maculopathy Recurrent major hypoglycaemia uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lewiston
State/Province
New York
ZIP/Postal Code
14092
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45291
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Connellsville
State/Province
Pennsylvania
ZIP/Postal Code
15425
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
København S
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
København
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Bagnols-sur-ceze
ZIP/Postal Code
30200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Carcassonne
ZIP/Postal Code
11000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Novo Nordisk Investigational Site
City
DAX
ZIP/Postal Code
40107
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MONTPELLIER cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Rueil-malmaison
ZIP/Postal Code
92501
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Cagliari
ZIP/Postal Code
09134
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Messina
ZIP/Postal Code
98123
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Bosch
ZIP/Postal Code
5216 GC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2584 HV
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Etten-Leur
ZIP/Postal Code
4872 LP
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Roelofarendsveen
ZIP/Postal Code
2371 RB
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3082 DC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Vlodrop
ZIP/Postal Code
6063 DA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
NO-5012
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Gjøvik
ZIP/Postal Code
NO-2819
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0370
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Trondheim
ZIP/Postal Code
NO-7030
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Almería
ZIP/Postal Code
04009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Gijón
ZIP/Postal Code
33206
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santa Cruz de Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valladolid
ZIP/Postal Code
47011
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17157113
Citation
Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. doi: 10.1016/j.clinthera.2006.10.020. Erratum In: Clin Ther. 2006 Nov;28(11):1967.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

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