Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | November 2011 |
NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)
This trial is conducted in Africa, Europe and the United States of America (USA).
The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue
(SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients
with type 1 diabetes.
The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension
period is registered as NN1250-3644.
The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue
(SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients
with type 1 diabetes.
The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension
period is registered as NN1250-3644.
Inclusion Criteria:
- Type 1 diabetes mellitus for at least 12 months
- Current treatment with any basal bolus insulin for at least 12 months
- HbA1c below or equal to 10.0%
- BMI (Body Mass Index) below or equal to 35.0 kg/m^2
- For the extension trial only: Completion of the 52 week treatment period in trial
NN1250-3583 (NCT00982228)
Exclusion Criteria:
- Use of any other antidiabetic drug than insulin within the last 3 months
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for
diabetic ketoacidosis during the previous 6 months
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures according to local requirements
- Cancer and medical history of cancer
We found this trial at
53
sites
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