Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: repaglinide; Drug: insulin NPH

• Registration Number: NCT01562561
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06-01
• Primary Completion: 2002-12-20
• Study Completion: 2002-12-20
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• Type 2 diabetes
• HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
• BMI (body mass index) maximum 35 kg/m^2

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rep + NPH	repaglinide	-
Rep + NPH	insulin NPH	-
NPH	insulin NPH	-

Primary Outcome Measures

Name	Time	Method
HbA1c (glycosylated haemoglobin)	Week 0 (visit 5); week 26

Secondary Outcome Measures

Name	Time	Method
FPG (fasting plasma glucose)	Week 0 (visit 5); week 26
7-point blood glucose profile	Week 0 (visit 5); week 26
Hypoglycaemic episodes	Week 0 (visit 5); week 26
Adverse events	Week 0 (Visit 5); week 26

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Tainan city, Taiwan