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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 characterized by an asymmetric insulin requirement across the day and night.


- candidate number1964
- NTR NumberNTR585
- ISRCTNISRCTN06622595
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR3-feb-2006
- Secondary IDsN/A 
- Public TitleA 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 across the day and night.
- Scientific TitleA 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.
- ACRONYMBIRDSONG-trial - Basal Insulin Requirement for Diabetes with Sunrise Or Nightfall Glucose escape.
- hypothesisInsulin 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus type 2 (DM type II)
- Inclusion criteria1. 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 OGLDs, and;
2. A ratio of evening insulin dose:morning insulin dose >1.3:1 (nocturnal hepatic glucose output subgroup), or
3. A ratio of morning insulin dose:evening insulin dose >1.3:1 (daytime insulin insensitivity subgroup).
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2006
- planned closingdate30-nov-2006
- Target number of participants175
- InterventionsRandomization 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.
- Primary outcomeThe 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 outcome1. 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, HDL cholesterol, LDL cholesterol;
9. Skin reactions to insulin injection, as reported by patients.
- Timepoints
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES S.G.H.A. Swinnen
- CONTACT for SCIENTIFIC QUERIESDr. J.H. Vries, de
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam), University of Newcastle upon Tyne
- Funding
(Source(s) of Monetary or Material Support)
Novo Nordisk Farma B.V.
- PublicationsN/A
- Brief summaryStudy title:
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 characterized by an asymmetric insulin requirement across the day and night.

Background:
As type 2 diabetes progresses, insulin therapy is generally needed to maintain acceptable blood glucose control. Traditionally, insulin therapy was often initiated by the addition, to prior oral glucose-lowering drugs (OGLDs), of twice daily injections of insulin formulations with an extended duration of action, such as NPH insulin. In recent years, the availability of the long-acting basal insulin analogues insulin glargine and detemir has led to the increasing introduction of insulin therapy by once-daily injection.
Yet, it is not unusual for people with type 2 diabetes to have different supplementary insulin requirements during the daytime and night-time. Accordingly, a formulation like insulin glargine, with a relatively flat profile of action reaching out to 24 hours, may imperfectly match the insulin supplementation needs of either group, whenever given. This suggests that an insulin with intermediate properties, such as insulin detemir, might, if injected at times aimed at matching the patientís physiological requirement, provide optimal control of hyperglycaemia, without causing the hypoglycaemia that can limit dose titration in clinical practice.

Objective:
The primary objective of this study is to assess whether insulin detemir, when injected once-daily at an individually appropriate time (either before breakfast or at bedtime), can provide 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.

Design and methods:
The trial is an open-label, randomized, twin parallel-group clinical trial in people with type 2 diabetes characterized by an asymmetrical insulin requirement across the day and night.

Population:
People with type 2 diabetes who have received treatment with either twice daily NPH insulin or a twice daily regimen of a premix insulin, for at least 2 months, with or without concomitant use of 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).

Intervention:
Randomization will be to once-daily insulin glargine given at bedtime or to insulin detemir given once daily either at this time or before breakfast, according to the patient subgroup. 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.

Primary endpoint:
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.

Burden for the participants:
The risk for participants is judged to be minor. During treatment with insulin analogues there havenít occurred any other side-effects than those during other insulin therapy. The main side-effect of any type of insulin therapy is the risk of hypoglycaemia. Participation mainly requires an investment of time.
- Main changes (audit trail)
- RECORD3-feb-2006 - 14-sep-2009


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