Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

Completed · Phase 4

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Key facts

Study ID

NCT00909480

Run by

Novo Nordisk A/S

People needed

457

Starts

2009-05-01

Expected to finish

2010-06-01

Last updated by the study team

2017-03-10

Who can join

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

You may qualify if…

• Diagnosed with type 2 diabetes for at least 6 months
• Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
• Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
• HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
• Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2

You may not qualify if…

• Any contraindication to insulin detemir or insulin glargine according to the local labelling
• Receipt of any investigational product within 4 weeks
• Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
• Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
• Any other condition that the Investigator feels would interfere with trial participation or evaluation of results

Where it is running

• Novo Nordisk Investigational Site — Searcy, Arkansas, United States
• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Escondido, California, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Redlands, California, United States
• Novo Nordisk Investigational Site — Santa Ana, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Norwalk, Connecticut, United States
• Novo Nordisk Investigational Site — Hollywood, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Ocala, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Plantation, Florida, United States
• Novo Nordisk Investigational Site — Ponte Vedra, Florida, United States
• Novo Nordisk Investigational Site — Winter Haven, Florida, United States
• Novo Nordisk Investigational Site — Powder Springs, Georgia, United States
• Novo Nordisk Investigational Site — Roswell, Georgia, United States
• Novo Nordisk Investigational Site — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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