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

A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01720303

Enrollment

159

Registered

2012-11-02

Start date

2002-09-19

Completion date

2003-04-10

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. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.

Interventions

DRUGrepaglinide

2 mg (tablets) before each main meal

DRUGisophane human insulin

Injection s.c. (under the skin) at bedtime

DRUGinsulin

Injection s.c. (under the skin) twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* HbA1c between 7.5 % and 13.0% (both inclusive) * Fasting C-peptide above or equal to 0.33 nmol/l * BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

Exclusion criteria

* Medical history of treatment with insulin within the last 6 months * Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)

Design outcomes

Primary

Measure	Time frame
Change in HbA1c	—

Secondary

Measure	Time frame
Change in FBG (Fasting Blood Glucose)	—
Change in body weight	—

Countries

China

Outcome results

None listed

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