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Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00568984
Enrollment
324
Registered
2007-12-06
Start date
2002-11-21
Completion date
2003-11-10
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 investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes

Interventions

DRUGrepaglinide
DRUGmetformin
DRUGglicazide

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes for at least 3 months * No previous treatment for diabetes * HbA1c between 7.0-12.0% * Body Mass Index (BMI) between 19.0-40.0 kg/m2

Exclusion criteria

* Type 1 diabetes * Known unstable/untreated proliferative retinopathy * Uncontrolled treated/untreated hypertension * Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures

Design outcomes

Primary

MeasureTime frame
HbA1cafter 16 weeks of treatment

Secondary

MeasureTime frame
Glucose profiles
Quality of life assessment
Treatment satisfaction
Hypoglycaemic events
Adverse events

Countries

China, Malaysia, Philippines, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026