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

Novo Nordisk A/S213 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

213

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

repaglinideDRUG

2 mg at each main meal

insulin NPHDRUG

Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Novo Nordisk Investigational Site

Shatin, New Territories, Hong Kong

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, Malaysia

Novo Nordisk Investigational Site

Marikina City, Philippines

Outcomes

Primary Outcomes

HbA1c (glycosylated haemoglobin)

Time frame: Week 0 (visit 5); week 26

Secondary Outcomes

FPG (fasting plasma glucose)

Time frame: Week 0 (visit 5); week 26

7-point blood glucose profile

Time frame: Week 0 (visit 5); week 26

Hypoglycaemic episodes

Time frame: Week 0 (visit 5); week 26

Adverse events

Time frame: Week 0 (Visit 5); week 26

Data from ClinicalTrials.gov

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