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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25809

Enrollment

175

Registered

2006-02-03

Start date

2006-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes.

Interventions

Randomization 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 subgrou

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. Patients with HbA1c >9.0 or 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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, HDL cholesterol, LDL cholesterol; 9. Skin reactions to insulin injection, as reported by patients.	—

Measure

Time frame

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, HDL cholesterol, LDL cholesterol; 9. Skin reactions to insulin injection, as reported by patients.

—

Contacts

Public ContactS.G.H.A. Swinnen

Academic Medical Center, Department of Internal Medicine F4-257, P.O. box 22660

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)