Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Duration of type 2 diabetes mellitus for at least one year
Insulin naive patients
OHA treatment for at least 12 weeks
HbA1C between 7.5-10.0%
Body Mass Index (BMI) below 30.0 kg/m2
Impaired renal function
Impaired hepatic function
Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 36-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Once Daily Treatment as an Add-on Current Oral Hypoglycemic Agents. J. Japan Diab. Soc 2007; 50 (9): 665-677
Tajima N, Iwamoto Y, Kaku K, Kawamori R, Nishida T, Kobayashi M. Once-daily insulin detemir added to oral antidiabetic drugs results in less weight gain and a trend for reduced hypoglycaemia in comparison with NPH insulin in Japanese patients with type 2 diabetes. Diabetologia 2006; 49 (Suppl. 1): 609 (Abstract 996)