Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

Completed · Phase 2

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Key facts

Study ID

NCT00611884

Run by

Novo Nordisk A/S

People needed

245

Starts

2008-01-01

Expected to finish

2008-08-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
• Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months)
• Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI
• HbA1c 7.0-11.0 % (both inclusive)
• Body Mass Index (BMI) 23-42 kg/m\^2 [lb/in\^2 x 703] (both inclusive)

You may not qualify if…

• Metformin contraindication according to local practice
• Thiazolidinedione (TZD) treatment within previous three months prior to visit 1
• Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
• Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug

Where it is running

• Novo Nordisk Investigational Site — Inglewood, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Redlands, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Idaho Falls, Idaho, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Springfield, Illinois, United States
• Novo Nordisk Investigational Site — Greensboro, North Carolina, United States
• Novo Nordisk Investigational Site — Medford, Oregon, United States
• Novo Nordisk Investigational Site — Simpsonville, South Carolina, United States
• Novo Nordisk Investigational Site — Kingsport, Tennessee, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States
• Novo Nordisk Investigational Site — Newport News, Virginia, United States
• Novo Nordisk Investigational Site — Renton, Washington, United States
• Novo Nordisk Investigational Site — Milwaukee, Wisconsin, United States
• Novo Nordisk Investigational Site — Cambridge, Ontario, Canada
• Novo Nordisk Investigational Site — Etobicoke, Ontario, Canada
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Hyderabad, Andhra Pradesh, India
• Novo Nordisk Investigational Site — Kochi, Kerala, India
• Novo Nordisk Investigational Site — Mumbai, Maharashtra, India

Full record on ClinicalTrials.gov

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