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

Overview[ - collapse ][ - ]

Purpose 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
ConditionDiabetes
Diabetes Mellitus, Type 2
InterventionDrug: repaglinide
Drug: metformin
Drug: glicazide
PhasePhase 4
SponsorNovo Nordisk A/S
Responsible PartyNovo Nordisk A/S
ClinicalTrials.gov IdentifierNCT00568984
First ReceivedDecember 4, 2007
Last UpdatedJune 5, 2012
Last verifiedJanuary 2012

Tracking Information[ + expand ][ + ]

First Received DateDecember 4, 2007
Last Updated DateJune 5, 2012
Start DateNovember 2002
Estimated Primary Completion DateNovember 2003
Current Primary Outcome MeasuresHbA1c [Time Frame: after 16 weeks of treatment] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • glucose profiles [Designated as safety issue: No]
  • Quality of life assessment [Designated as safety issue: No]
  • Treatment satisfaction [Designated as safety issue: No]
  • Hypoglycaemic events [Designated as safety issue: No]
  • Adverse events [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
Official TitleEfficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
InterventionDrug: repaglinide
Drug: metformin
Drug: glicazide
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment324
Estimated Completion DateNovember 2003
Estimated Primary Completion DateNovember 2003
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina, Malaysia, Philippines, Thailand

Administrative Information[ + expand ][ + ]

NCT Number NCT00568984
Other Study ID NumbersAGEE-3017
Has Data Monitoring CommitteeNo
Information Provided ByNovo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators Study Director: Jing Ping Yeo Novo Nordisk Asia Pacific Pte.
Verification DateJanuary 2012

Locations[ + expand ][ + ]

China, Beijing
Beijing, Beijing, China, 100034
Malaysia
Cheras, Malaysia, 56000
Philippines
Manila, Philippines, 1003
Thailand
Bangkok, Thailand, 10330