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

Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00799448

Enrollment

Registered

2008-11-27

Start date

2003-09-16

Completion date

2004-09-20

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 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

Interventions

DRUGrepaglinide

DRUGbiphasic human insulin 30

DRUGinsulin NPH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1c	after 20 weeks of treatment

Secondary

Measure	Time frame
Fasting blood glucose (FBG)	—
Incidence of hypoglycaemic episodes	—
Adverse events	—

Countries

Greece

Outcome results

None listed

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