PreFER: Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00605020

Collaborator

(none)

719

Enrollment

127

Locations

Actual Duration (Months)

5.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

719 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

Actual Study Start Date :

Dec 2, 2003

Actual Primary Completion Date :

Mar 3, 2005

Actual Study Completion Date :

Mar 3, 2005

Outcome Measures

Primary Outcome Measures

HbA1c [after 6 months of treatment]

Secondary Outcome Measures

Incidence of hypoglycaemic episodes []
Adverse events []
Difference of HbA1c change between the two groups [after 13 weeks of treatment]
Fasting plasma glucose of treatment [after 13 and 26 weeks]
Change in weight []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetes
Duration of type 2 diabetes for at least 6 months since diagnosis
Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
BMI below 40 kg/m2
HbA1c between 7-12%
Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria:

Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
Known or suspected allergy to trial product or related products
Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
Receipt of any investigational drug within 4 weeks prior to this trial
Previous participation in this trial

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Graz	Austria	8036
2	Novo Nordisk Investigational Site	Linz	Austria	4021
3	Novo Nordisk Investigational Site	Wien	Austria	1230
4	Novo Nordisk Investigational Site	Wien	Austria	A 1090
5	Novo Nordisk Investigational Site	Wien	Austria	A-1130
6	Novo Nordisk Investigational Site	Alsdorf	Germany	52477
7	Novo Nordisk Investigational Site	Altenburg	Germany	04600
8	Novo Nordisk Investigational Site	Altenkirchen	Germany	57610
9	Novo Nordisk Investigational Site	Altenstadt	Germany	63674
10	Novo Nordisk Investigational Site	Aschaffenburg	Germany	63739
11	Novo Nordisk Investigational Site	Augsburg	Germany	86150
12	Novo Nordisk Investigational Site	Bad Harzburg	Germany	38667
13	Novo Nordisk Investigational Site	Bad Heilbrunn	Germany	83670
14	Novo Nordisk Investigational Site	Bad Kreuznach	Germany	55545
15	Novo Nordisk Investigational Site	Bad Lauterberg	Germany	37431
16	Novo Nordisk Investigational Site	Bad Lippspringe	Germany	33175
17	Novo Nordisk Investigational Site	Bad Mergentheim	Germany	97980
18	Novo Nordisk Investigational Site	Bad Neuenahr-Ahrweiler	Germany	53474
19	Novo Nordisk Investigational Site	Bad Oldesloe	Germany	23843
20	Novo Nordisk Investigational Site	Bad Staffelstein	Germany	96231
21	Novo Nordisk Investigational Site	Bensheim	Germany	64625
22	Novo Nordisk Investigational Site	Berlin	Germany	10318
23	Novo Nordisk Investigational Site	Berlin	Germany	10559
24	Novo Nordisk Investigational Site	Berlin	Germany	10789
25	Novo Nordisk Investigational Site	Berlin	Germany	12203
26	Novo Nordisk Investigational Site	Berlin	Germany	12687
27	Novo Nordisk Investigational Site	Berlin	Germany	13055
28	Novo Nordisk Investigational Site	Bochum	Germany	44791
29	Novo Nordisk Investigational Site	Damme	Germany	49401
30	Novo Nordisk Investigational Site	Diez	Germany	65582
31	Novo Nordisk Investigational Site	Dinslaken	Germany	46537
32	Novo Nordisk Investigational Site	Dormagen	Germany	41539
33	Novo Nordisk Investigational Site	Dortmund	Germany	44145
34	Novo Nordisk Investigational Site	Dortmund	Germany	44225
35	Novo Nordisk Investigational Site	Dresden	Germany	01219
36	Novo Nordisk Investigational Site	Dresden	Germany	01307
37	Novo Nordisk Investigational Site	Duisburg	Germany	47051
38	Novo Nordisk Investigational Site	Duisburg	Germany	47179
39	Novo Nordisk Investigational Site	Emmerich	Germany	46446
40	Novo Nordisk Investigational Site	Essen	Germany	45307
41	Novo Nordisk Investigational Site	Essen	Germany	45329
42	Novo Nordisk Investigational Site	Flensburg	Germany	24939
43	Novo Nordisk Investigational Site	Flörsheim	Germany	65439
44	Novo Nordisk Investigational Site	Forchheim	Germany	91301
45	Novo Nordisk Investigational Site	Frankfurt	Germany	60325
46	Novo Nordisk Investigational Site	Frankfurt	Germany	60326
47	Novo Nordisk Investigational Site	Frankfurt	Germany	60433
48	Novo Nordisk Investigational Site	Frankfurt	Germany	60590
49	Novo Nordisk Investigational Site	Freiburg	Germany	79106
50	Novo Nordisk Investigational Site	Freital	Germany	01705
51	Novo Nordisk Investigational Site	Gebhardshain	Germany	57580
52	Novo Nordisk Investigational Site	Genthin	Germany	39307
53	Novo Nordisk Investigational Site	Georgsmarienhütte	Germany	49124
54	Novo Nordisk Investigational Site	Giessen	Germany	35390
55	Novo Nordisk Investigational Site	Gotha	Germany	99867
56	Novo Nordisk Investigational Site	Halle	Germany	06114
57	Novo Nordisk Investigational Site	Hamburg	Germany	20097
58	Novo Nordisk Investigational Site	Hamburg	Germany	20251
59	Novo Nordisk Investigational Site	Hamburg	Germany	22041
60	Novo Nordisk Investigational Site	Hamburg	Germany	22607
61	Novo Nordisk Investigational Site	Hameln	Germany	31785
62	Novo Nordisk Investigational Site	Hannover	Germany	30167
63	Novo Nordisk Investigational Site	Herne	Germany	44653
64	Novo Nordisk Investigational Site	Herrenberg	Germany	71083
65	Novo Nordisk Investigational Site	Hildesheim	Germany	31139
66	Novo Nordisk Investigational Site	Hohenmölsen	Germany	06679
67	Novo Nordisk Investigational Site	Hünxe	Germany	46569
68	Novo Nordisk Investigational Site	Idar-Oberstein	Germany	55743
69	Novo Nordisk Investigational Site	Jena	Germany	07743
70	Novo Nordisk Investigational Site	Kaiserslautern	Germany	67675
71	Novo Nordisk Investigational Site	Karlsruhe	Germany	76133
72	Novo Nordisk Investigational Site	Krummennaab	Germany	92703
73	Novo Nordisk Investigational Site	Künzing	Germany	94550
74	Novo Nordisk Investigational Site	Landau	Germany	76829
75	Novo Nordisk Investigational Site	Langen	Germany	63225
76	Novo Nordisk Investigational Site	Lindenfels	Germany	64678
77	Novo Nordisk Investigational Site	Lübeck	Germany	23562
78	Novo Nordisk Investigational Site	Mainz	Germany	55131
79	Novo Nordisk Investigational Site	Marburg	Germany	35037
80	Novo Nordisk Investigational Site	Marktheidenfeld	Germany	97828
81	Novo Nordisk Investigational Site	Meppen	Germany	49716
82	Novo Nordisk Investigational Site	Mühlheim	Germany	63165
83	Novo Nordisk Investigational Site	München	Germany	81737
84	Novo Nordisk Investigational Site	Neumünster	Germany	24534
85	Novo Nordisk Investigational Site	Neuwied	Germany	56564
86	Novo Nordisk Investigational Site	Nittenau	Germany	93149
87	Novo Nordisk Investigational Site	Northeim	Germany	37154
88	Novo Nordisk Investigational Site	Oberhausen	Germany	46145
89	Novo Nordisk Investigational Site	Oberndorf	Germany	78727
90	Novo Nordisk Investigational Site	Oberursel	Germany	61440
91	Novo Nordisk Investigational Site	Offenbach	Germany	63065
92	Novo Nordisk Investigational Site	Osnabrück	Germany	49080
93	Novo Nordisk Investigational Site	Pforzheim	Germany	75172
94	Novo Nordisk Investigational Site	Pirna	Germany	01796
95	Novo Nordisk Investigational Site	Regensburg	Germany	93059
96	Novo Nordisk Investigational Site	Rehlingen-Siersburg	Germany	66780
97	Novo Nordisk Investigational Site	Saaldorf-Surheim	Germany	83416
98	Novo Nordisk Investigational Site	Saarbrücken	Germany	66121
99	Novo Nordisk Investigational Site	Sangerhausen	Germany	06526
100	Novo Nordisk Investigational Site	Schaafheim	Germany	64850
101	Novo Nordisk Investigational Site	Schkeuditz	Germany	04435
102	Novo Nordisk Investigational Site	Schlüchtern	Germany	36381
103	Novo Nordisk Investigational Site	Schwerin	Germany	19049
104	Novo Nordisk Investigational Site	Schwerin	Germany	19059
105	Novo Nordisk Investigational Site	Schwerte	Germany	58239
106	Novo Nordisk Investigational Site	Siegen	Germany	57072
107	Novo Nordisk Investigational Site	Simmern	Germany	55469
108	Novo Nordisk Investigational Site	Sinsheim	Germany	74889
109	Novo Nordisk Investigational Site	Speyer	Germany	67346
110	Novo Nordisk Investigational Site	St. Ingbert	Germany	66386
111	Novo Nordisk Investigational Site	Stuttgart	Germany	70184
112	Novo Nordisk Investigational Site	Sulzbach-Rosenberg	Germany	92237
113	Novo Nordisk Investigational Site	Sögel	Germany	49751
114	Novo Nordisk Investigational Site	Trier	Germany	54290
115	Novo Nordisk Investigational Site	Tübingen	Germany	72072
116	Novo Nordisk Investigational Site	Völklingen	Germany	66333
117	Novo Nordisk Investigational Site	Wallerfing	Germany	94574
118	Novo Nordisk Investigational Site	Wangen	Germany	88239
119	Novo Nordisk Investigational Site	Warburg	Germany	34414
120	Novo Nordisk Investigational Site	Wiesbaden	Germany	65191
121	Novo Nordisk Investigational Site	Wilhelmshaven	Germany	26382
122	Novo Nordisk Investigational Site	Würzburg	Germany	97072
123	Novo Nordisk Investigational Site	Basel-Bruderholz	Switzerland	4101
124	Novo Nordisk Investigational Site	Genève 14	Switzerland	1211
125	Novo Nordisk Investigational Site	Lugano	Switzerland	6900
126	Novo Nordisk Investigational Site	St. Gallen	Switzerland	9000
127	Novo Nordisk Investigational Site	Zürich	Switzerland	8002