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

Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01562561

Enrollment

213

Registered

2012-03-26

Start date

2001-06-01

Completion date

2002-12-20

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGrepaglinide

2 mg at each main meal

DRUGinsulin NPH

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
HbA1c (glycosylated haemoglobin)	Week 0 (visit 5); week 26

Secondary

Measure	Time frame
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

Countries

Hong Kong, Malaysia, Philippines, South Africa, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026