FindTrial
Sign In

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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003824-21-GB
Enrollment
Unknown
Registered
2007-05-15
Start date
2007-05-11
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Type 2 Diabetes MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Trade Name: Lantus Product Name: Lantus Pharmaceutical Form: Injection* Trade Name: Levemir Product Name: Levemir Pharmaceutical Form: Injection* Trade Name: NovoMix Product Name: Novomix 30 Pharmac

Sponsors

Royal Liverpool University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary end point(s): a. HbA1c. b. Fasting plasma glucose. c. 8 point blood glucose profile (pre- and 2 hours postprandial blood glucose measurements and at bedtime and at 0300 h). d. Daily blood glucose variability assessed by patient’s blood glucose monitoring diary. ;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.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026