Effects and comparisons of once & twice daily insulin’s in combination with oral hypoglycaemic agents on glycaemic control, hypoglycaemia and weight in type 2 Diabetes.

• Conditions: Type 2 Diabetes; MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2005-003824-21-GB
• Lead Sponsor: Royal Liverpool University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients with Type 2 Diabetes Mellitus:
a.Insulin naïve.
b.Men or Women.
c.Age between 40-80 years.
d.Duration of diabetes of at least 3 years.
2.HbA1c > 7.5%.
3.On maximum tolerated combination oral hypoglycaemic agents for more than 6 months.
4.BMI > 25.
5.All patients clinically requiring the commencement of insulin therapy.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Proliferative diabetic retinopathy requiring acute treatment.
2.Acute or chronic Renal failure.
3.Acute or chronic hepatic failure.
4.Severe Cardiac failure.
5.Allergy to insulin.
6.Alcohol dependence.
7.Pregnancy & Breast feeding.
8.Patients who have had ketoacidosis.
9.Previous treatment with insulin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): a.HbA1c.<br>b.Fasting plasma glucose.<br>c.8 point blood glucose profile (pre- and 2 hours postprandial blood glucose measurements and at bedtime and at 0300 h).<br>d.Daily blood glucose variability assessed by patient’s blood glucose monitoring diary.<br>;Main Objective: To determine and identify the most optimum insulin and oral hypoglycaemic agent combination to achieve maximum glycaemic control with the least hypoglycaemic events and little or no weight gain and even possible weight reduction.;Secondary Objective: To determine the effects of Insulin in combination with oral hypoglycaemic agents on glycaemic control, weight and hypoglycaemic events in poorly controlled type 2 Diabetes patients.