Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 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: | May 2011 |
NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational 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 ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)
This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).
The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin
glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without
pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the
long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with
or without metformin and with or without pioglitazone in subjects with type 2 diabetes.
All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial
participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.
Subjects who consent to participate in the extension trial (NN1250-3667) will continue to
receive the treatment to which they were randomly allocated in the 52 week trial
NN1250-3582.
The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension
period is registered as NN1250-3667.
The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin
glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without
pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the
long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with
or without metformin and with or without pioglitazone in subjects with type 2 diabetes.
All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial
participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.
Subjects who consent to participate in the extension trial (NN1250-3667) will continue to
receive the treatment to which they were randomly allocated in the 52 week trial
NN1250-3582.
The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension
period is registered as NN1250-3667.
Inclusion Criteria:
- For MAIN period (NN1250-3582):
- Type 2 diabetes mellitus for at least 6 months
- Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for
at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
- HbA1c 7.0-10.0 % (both inclusive)
- Body Mass Index (BMI) below or equal to 40.0 kg/m^2
- For EXTENSION period (NN1250-3667):
- Completion of the 52 week treatment period in NN1250-3582
Exclusion Criteria:
- For MAIN period (NN1250-3582):
- Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus
within 3 months
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures
- Cancer and medical history of cancer
We found this trial at
52
sites
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