Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00312104

Collaborator

(none)

325

Enrollment

Locations

Duration (Months)

7.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: insulin detemir Drug: insulin glargine Drug: insulin aspart	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

325 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Mar 1, 2003

Actual Study Completion Date :

Mar 1, 2003

Outcome Measures

Primary Outcome Measures

HbA1c [after 26 weeks of treatment]

Secondary Outcome Measures

Adverse events []
Body weight []
Blood glucose []
Hypoglycaemia []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 1 diabetes for at least 12 months
Current daily insulin dose of more than 1.4 IU/kg
BMI lesser than or equal to 35 kg/m2
HbA1c greater than 7.5% and less than or equal to 12.0%
In Austria, age more than 19 years

Exclusion Criteria:

Proliferate retinopathy or maculopathy
Recurrent major hypoglycaemia
Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Graz		Austria	8036
2	Novo Nordisk Investigational Site	Wien		Austria	1030
3	Novo Nordisk Investigational Site	Wien		Austria	1090
4	Novo Nordisk Investigational Site	Wien		Austria	A 1160
5	Novo Nordisk Investigational Site	Wien		Austria	A-1130
6	Novo Nordisk Investigational Site	Bad Kreuznach		Germany	55545
7	Novo Nordisk Investigational Site	Bad Mergentheim		Germany	97980
8	Novo Nordisk Investigational Site	Bad Neuenahr-Ahrweiler		Germany	53474
9	Novo Nordisk Investigational Site	Berlin		Germany	10789
10	Novo Nordisk Investigational Site	Diez		Germany	65582
11	Novo Nordisk Investigational Site	Erlangen		Germany	91052
12	Novo Nordisk Investigational Site	Essen		Germany	45138
13	Novo Nordisk Investigational Site	Flensburg		Germany	24939
14	Novo Nordisk Investigational Site	Frankfurt		Germany	60590
15	Novo Nordisk Investigational Site	Friedrichsthal		Germany	66299
16	Novo Nordisk Investigational Site	Genthin		Germany	39307
17	Novo Nordisk Investigational Site	Halle		Germany	06120
18	Novo Nordisk Investigational Site	Hamburg		Germany	20251
19	Novo Nordisk Investigational Site	Hannover		Germany	30171
20	Novo Nordisk Investigational Site	Heidelberg		Germany	69115
21	Novo Nordisk Investigational Site	Hennigsdorf		Germany	16761
22	Novo Nordisk Investigational Site	Hünxe		Germany	46569
23	Novo Nordisk Investigational Site	Jena		Germany	07743
24	Novo Nordisk Investigational Site	Kiel		Germany	24105
25	Novo Nordisk Investigational Site	Landau		Germany	76829
26	Novo Nordisk Investigational Site	Ludwigshafen		Germany	67059
27	Novo Nordisk Investigational Site	Marl		Germany	45770
28	Novo Nordisk Investigational Site	Mönchengladbach		Germany	41061
29	Novo Nordisk Investigational Site	Neunkirchen		Germany	66538
30	Novo Nordisk Investigational Site	Neuss		Germany	41460
31	Novo Nordisk Investigational Site	Northeim		Germany	37154
32	Novo Nordisk Investigational Site	Nürnberg		Germany	90402
33	Novo Nordisk Investigational Site	Rehlingen-Siersburg		Germany	66780
34	Novo Nordisk Investigational Site	Rheda-Wiedenbrück		Germany	33378
35	Novo Nordisk Investigational Site	Saarbrücken		Germany	66121
36	Novo Nordisk Investigational Site	Saarlouis		Germany	66740
37	Novo Nordisk Investigational Site	Schwabenheim		Germany	55270
38	Novo Nordisk Investigational Site	Schwerin		Germany	19049
39	Novo Nordisk Investigational Site	Schönebeck		Germany	39218
40	Novo Nordisk Investigational Site	Völklingen		Germany	66333
41	Novo Nordisk Investigational Site	Wiesbaden		Germany	65183
42	Novo Nordisk Investigational Site	Würzburg		Germany	97072
43	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2193
44	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4091
45	Novo Nordisk Investigational Site	Cape Town	Western Cape	South Africa	7130
46	Novo Nordisk Investigational Site	Cape Town	Western Cape	South Africa	7925