A comparison of once daily insulin detemir given pre-breakfast or bedtime, according to need, with bedtime insulin glargine in people with type 2 diabetes characterised by an asymmetric insulin requirement across the day and night

ISRCTN	ISRCTN06622595
DOI	https://doi.org/10.1186/ISRCTN06622595
Protocol serial number	NTR585
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Novo Nordisk BV (Netherlands)

Submission date: 08/03/2006
Registration date: 08/03/2006
Last edited: 24/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S.G.H.A. Swinnen
Scientific

Academic Medical Center
Department of Internal Medicine F4-257
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5667836
Email	S.G.Swinnen@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Added 24/08/09: A multicentre, open-label, randomized comparison of once daily insulin detemir given pre-breakfast or bedtime, according to need, with bedtime insulin glargine in people with type 2 diabetes characterized by an asymmetric insulin requirement between the day and night.
Study acronym	BIRDSONG-trial
Study objectives	Insulin detemir, when injected once daily at an individually appropriate time (either before breakfast or at bedtime), provides superior glycaemic control to insulin glargine injected indiscriminately at bedtime in patients that had clearly different dose requirements, day and night, when their insulin was previously given as a twice daily regimen. Basal Insulin Requirement for Diabetes with Sunrise Or Nightfall Glucose escape (BIRDSONG)
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Diabetes mellitus type II (DM type II)
Intervention	Randomisation will be to once-daily insulin glargine given at bedtime (or late evening) or to insulin detemir given once daily either at this time or before breakfast, according to the patient subgroup. The initial insulin dose will be determined as the greater of the two prior daily insulin doses. OGLD therapy will remain unchanged throughout the trial. Each treatment period will be for 16 weeks, involving forced dose titration throughout. Insulin dose will be continually titrated against pre-breakfast or pre-dinner (depending on group) plasma glucose, and will be curtailed by confirmed hypoglycaemia at any time. For those receiving insulin detemir pre-breakfast, the titration target is pre-dinner plasma glucose <5.6 mmol/l. For those receiving insulin glargine or insulin detemir at bedtime the target is pre-breakfast plasma glucose <5.6 mmol/l.
Intervention type	Other
Primary outcome measure(s)	The percentage of participants achieving the following criteria: pre-breakfast plasma glucose <5.6 mmol/l and pre-dinner plasma glucose <6.9 mmol/l, without hypoglycaemia, confirmed by a blood glucose reading of <3.5 mmol/l.
Key secondary outcome measure(s)	1. HbA1c at endpoint 2 Change in HbA1c over the study 3. Mean and coefficient of variation of fasting and pre-dinner blood glucose levels 4. 9-point blood glucose profiles 5. Hypoglycaemia event rates throughout the study period and in last 12 weeks of study 6. Body weight at baseline and at endpoint 7. Blood pressure 8. Triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol 9. Skin reactions to insulin injection, as reported by patients
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	175
Key inclusion criteria	People with type 2 diabetes who have received treatment with either twice daily NPH insulin or a twice daily regimen of a human or analogue (30/70) premix insulin, either regimen for at least 2 months, with or without concomitant use of oral glucose-lowering drugs (OGLDs) and: 1. A ratio of evening insulin dose:morning insulin dose >1.3:1 (nocturnal hepatic glucose output subgroup), or 2. A ratio of morning insulin dose:evening insulin dose >1.3:1 (daytime insulin insensitivity subgroup)
Key exclusion criteria	1. Patients with HbA1c >9.0 or <6.5% at entry visit 2. Patients with body mass index >40.0 kg/m2 at entry visit 3. Patients who are pregnant or for whom pregnancy during the trial is a possibility 4. Patients currently receiving treatment with thiazolidinediones or meglitinide derivatives, that cannot be stopped for the duration of the trial 5. Patients with high insulin dose requirements >100 U/day at entry visit 6. Patients on mixed insulin regimens, such as NPH insulin and a premixed insulin, or different ratios of premixed insulin morning and evening 7. Patients with known or suspected allergy to trial products or related products 8. Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Date of first enrolment	01/04/2006
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan