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 4

Terminated

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00799448
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-16
• Primary Completion: 2004-09-20
• Study Completion: 2004-09-20
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 20 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose (FBG)
Incidence of hypoglycaemic episodes
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇷 Athens, Greece