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

Phase 4TerminatedNCT00799448

Novo Nordisk A/S40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

repaglinideDRUG

biphasic human insulin 30DRUG

insulin NPHDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Athens, Greece

Outcomes

Primary Outcomes

HbA1c

Time frame: after 20 weeks of treatment

Secondary Outcomes

Fasting blood glucose (FBG)

Incidence of hypoglycaemic episodes

Adverse events

Data from ClinicalTrials.gov

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