Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00097084

Collaborator

(none)

324

Enrollment

Locations

Duration (Months)

5.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin detemir Drug: insulin glargine Drug: insulin aspart	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

HbA1c [after 1 year trial period]

Secondary Outcome Measures

Adverse events []
Body weight []
Hypoglycemia []
Blood glucose []
Insulin Treatment Satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetes for at least 12 months
Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
BMI of maximum 40 kg/m2
HbA1c greater than or equal to 7.0% and less than or equal to 11.0%

Exclusion Criteria:

Proliferative retinopathy or maculopathy
Recurrent major hypoglycaemia
Impaired hepatic or renal function
Cardiac problems or uncontrolled hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Little Rock	Arkansas	United States	72204
2	Novo Nordisk Investigational Site	Inglewood	California	United States	90301
3	Novo Nordisk Investigational Site	San Francisco	California	United States	94143-0780
4	Novo Nordisk Investigational Site	Santa Ana	California	United States	92705
5	Novo Nordisk Investigational Site	Spring Valley	California	United States	91978
6	Novo Nordisk Investigational Site	Boca Raton	Florida	United States	33433
7	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
8	Novo Nordisk Investigational Site	Lake Mary	Florida	United States	32746
9	Novo Nordisk Investigational Site	Melbourne	Florida	United States	32901
10	Novo Nordisk Investigational Site	Orlando	Florida	United States	32804
11	Novo Nordisk Investigational Site	Palm Harbor	Florida	United States	34684
12	Novo Nordisk Investigational Site	Vero Beach	Florida	United States	32960
13	Novo Nordisk Investigational Site	Athens	Georgia	United States	30606
14	Novo Nordisk Investigational Site	Idaho Falls	Idaho	United States	83404-7596
15	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
16	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68114
17	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89119-6100
18	Novo Nordisk Investigational Site	Berlin	New Jersey	United States	08009
19	Novo Nordisk Investigational Site	Asheville	North Carolina	United States	28803
20	Novo Nordisk Investigational Site	Hermitage	Pennsylvania	United States	16148
21	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19107
22	Novo Nordisk Investigational Site	Dallas	Texas	United States	75235
23	Novo Nordisk Investigational Site	Dallas	Texas	United States	75246
24	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390-8858
25	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229
26	Novo Nordisk Investigational Site	Newport News	Virginia	United States	23606
27	Novo Nordisk Investigational Site	Richmond	Virginia	United States	23249
28	Novo Nordisk Investigational Site	Tacoma	Washington	United States	98405
29	Novo Nordisk Investigational Site	Espoo		Finland	02740
30	Novo Nordisk Investigational Site	Helsinki		Finland	00260
31	Novo Nordisk Investigational Site	Kurikka		Finland	FI-61300
32	Novo Nordisk Investigational Site	Lahti		Finland	FI-15110
33	Novo Nordisk Investigational Site	Lapua		Finland	FI-62100
34	Novo Nordisk Investigational Site	Oulu		Finland	FI-90220
35	Novo Nordisk Investigational Site	Turku		Finland	20700
36	Novo Nordisk Investigational Site	Brest		France	29200
37	Novo Nordisk Investigational Site	Le Mans		France
38	Novo Nordisk Investigational Site	MONTPELLIER cedex 5		France	34295
39	Novo Nordisk Investigational Site	Nanterre		France	92014
40	Novo Nordisk Investigational Site	Narbonne		France	11108
41	Novo Nordisk Investigational Site	NEVERS cedex		France	58033
42	Novo Nordisk Investigational Site	Orleans		France
43	Novo Nordisk Investigational Site	Paris		France	75181
44	Novo Nordisk Investigational Site	Venissieux		France	69200
45	Novo Nordisk Investigational Site	Bergen		Norway	NO-5009
46	Novo Nordisk Investigational Site	Notodden		Norway	NO-3675
47	Novo Nordisk Investigational Site	Sarpsborg		Norway	1723
48	Novo Nordisk Investigational Site	Ski		Norway	NO-1400
49	Novo Nordisk Investigational Site	Stavanger		Norway	4011
50	Novo Nordisk Investigational Site	Trondheim		Norway	NO-7030
51	Novo Nordisk Investigational Site	Falun		Sweden	791 82
52	Novo Nordisk Investigational Site	Göteborg		Sweden	417 17
53	Novo Nordisk Investigational Site	Kalmar		Sweden	391 85
54	Novo Nordisk Investigational Site	Lund		Sweden	221 85
55	Novo Nordisk Investigational Site	Lund		Sweden	223 70
56	Novo Nordisk Investigational Site	Malmö		Sweden	214 26
57	Novo Nordisk Investigational Site	Motala		Sweden	591 85
58	Novo Nordisk Investigational Site	Oskarshamn		Sweden	572 28
59	Novo Nordisk Investigational Site	Uddevalla		Sweden	451 50
60	Novo Nordisk Investigational Site	Ängelholm		Sweden	262 91