Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes
Status and phase
Completed
Phase 3
Conditions
Diabetes
Diabetes Mellitus, Type 2
Treatments
Drug: insulin NPH
Drug: insulin detemir
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.
Enrollment
503 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Type 2 diabetes for at least 12 months
- Currently treated with Oral Antidiabetic Drugs
- BMI lesser than or equal to 40 kg/m2
- HbA1c greater than or equal 7.5 and lesser than or equal to 11%
Exclusion criteria
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
96
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Data sourced from clinicaltrials.gov
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