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.
Suspended
- Conditions
- Type 2 diabetes.
- Registration Number
- NL-OMON25809
- Lead Sponsor
- Dr. J.H. de VriesAcademic Medical Center - AmsterdamandProf. Philip HomeUniversity of Newcastle upon Tyne, UK
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 175
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
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of participants achieving the following criteria: <br>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.<br>
- Secondary Outcome Measures
Name Time Method 1. HbA1c at endpoint; <br /><br>2 Change in HbA1c over the study;<br /><br>3. Mean and coefficient of variation of fasting and pre-dinner blood glucose levels; <br /><br>4. 9-point blood glucose profiles; <br /><br>5. Hypoglycaemia event rates throughout the study period and in last 12 weeks of study;<br /><br>6. Body weight at baseline and at endpoint; <br /><br>7. Blood pressure;<br /><br>8. Triglycerides, HDL cholesterol, LDL cholesterol;<br /><br>9. Skin reactions to insulin injection, as reported by patients.