Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Terminated; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic human insulin 30; Drug: repaglinide; Drug: insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799448

AGEE-1524

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy

Enrollment: 40 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• HbA1c: 7.5-11.0% on current therapy
• OHA (oral hypoglycaemic agent) treatment for a minimum of two years
• BMI (body mass index): 25-32 kg/m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)