Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00972283

Run by

Novo Nordisk A/S

People needed

1006

Starts

2009-09-01

Expected to finish

2010-10-28

Last updated by the study team

2017-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Birmingham, Alabama, United States
• Novo Nordisk Investigational Site — Goodyear, Arizona, United States
• Novo Nordisk Investigational Site — Peoria, Arizona, United States
• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — Huntington Beach, California, United States
• Novo Nordisk Investigational Site — Los Gatos, California, United States
• Novo Nordisk Investigational Site — Salinas, California, United States
• Novo Nordisk Investigational Site — Santa Monica, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Tustin, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Milford, Connecticut, United States
• Novo Nordisk Investigational Site — Norwalk, Connecticut, United States
• Novo Nordisk Investigational Site — Waterbury, Connecticut, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Gainesville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Lake Mary, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Plantation, Florida, United States
• Novo Nordisk Investigational Site — West Palm Beach, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Fort Valley, Georgia, United States
• Novo Nordisk Investigational Site — Honolulu, Hawaii, United States
• Novo Nordisk Investigational Site — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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