Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
24/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S.G.H.A. Swinnen

ORCID ID

Contact details

Academic Medical Center
Department of Internal Medicine F4-257
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5667836
S.G.Swinnen@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR585

Study information

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.

Acronym

BIRDSONG-trial

Study hypothesis

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

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/04/2006

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

175

Participant 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

Recruitment start date

01/04/2006

Recruitment end date

30/11/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Novo Nordisk BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes