| Trial name or title | A 26‐week randomised, multinational, open‐labelled, 2‐armed, parallel group, treat‐to‐target once‐daily treatment trial with insulin detemir versus insulin glargine, both in combination with metformin in subjects with type 2 diabetes. |
| Methods | Intervention study, randomised, open‐label, active‐control, parallel assignment, safety/efficacy study. |
| Participants | Inclusion criteria: diagnosed with type 2 diabetes for at least 6 months, age 18 years and older, 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 OGLD (sulphonylureas, meglitinides, thiazolidinediones or DPP‐4 inhibitors) for at least 3 months, insulin‐naive (short‐term insulin treatment of up to 14 days is allowed), HbA1c between 7.0% and 9.0 % (both inclusive), and BMI ≤ 35.0 kg/m2. Exclusion criteria: 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 or any other condition that the Investigator feels would interfere with trial participation or evaluation of results. |
| Interventions | Insulin detemir: Treat‐to‐target titration according to titration algorithm. Subcutaneous injection once‐daily. Insulin glargine: Treat‐to‐target titration according to titration algorithm. Subcutaneous injection once‐daily. |
| Outcomes | Change in HbA1C from baseline, proportion of subjects achieving HbA1c ≤ 7.0%, proportion of subjects achieving HbA1c ≤ 6.5%, FPG, within‐subject variation of self‐measured PG, 9‐point PG profile, incidence of hypoglycaemic episodes during the trial (nocturnal and over 24 hours) and change in body weight. |
| Starting date | May 2009. |
| Contact information | Novo Nordisk clinical trial call centre (866‐867‐7178). |
| Notes | Estimated completion date: June 2010. |
Anti‐GAD = anti‐Glutamic Acid Decarboxylase; BMI = body mass index; DPP‐4 = dipeptidyl peptidase‐4; FBG = fasting blood glucose, FPG = fasting plasma glucose; HbA1c = glycosylated haemoglobin A1c; MRI = magnetic resonance imaging; NYHA = New York Heart Association; OGLD = oral glucose‐lowering drug; PAEE = physical activity energy expenditure; PG = plasma glucose; RMR = resting metabolic rate; SNRIs = serotonin‐norepinephrine reuptake inhibitors; SSRIs = selective serotonin reuptake inhibitors; TEE = total energy expenditure; TEF = thermic effects of food; TIA = transient ischaemic attack.