Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

A Multi-centre, Single Armed, Open Labelled Trial to Study the Efficacy and Safety Profile of Repaglinide & Metformin Combination Therapy in Chinese Type 2 Diabetics

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00491725

Enrollment

187

Registered

2007-06-26

Start date

2005-09-30

Completion date

2006-06-30

Last updated

2016-03-03

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 evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

Interventions

DRUGrepaglinide

DRUGmetformin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes for at least 12 weeks * HbA1c: 8.0-10.0% * Current treatment with OAD on monotheray or OAD on combination therapy * Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion criteria

* Known or suspected allergy to trial product(s) or related products * Recurrent major hypoglycaemia as judged by the Investigator * Uncontrolled hypertension * Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator

Design outcomes

Primary

Measure	Time frame
HbA1c	after 18 weeks of treatment

Secondary

Measure	Time frame
Post Prandial Plasma Glucose	—
Fasting Plasma Glucose (FPG)	—
Safety profile	—

Countries

China

Outcome results

None listed

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