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

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Novo Nordisk

Status and phase

Completed
Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: glicazide
Drug: metformin
Drug: repaglinide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00568984
AGEE-3017

Details and patient eligibility

About

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

Enrollment

324 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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