Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.
ConditionDiabetes
Diabetes Mellitus, Type 2
InterventionDrug: metformin
Drug: repaglinide
PhasePhase 4
SponsorNovo Nordisk A/S
Responsible PartyNovo Nordisk A/S
ClinicalTrials.gov IdentifierNCT01465152
First ReceivedOctober 31, 2011
Last UpdatedNovember 3, 2011
Last verifiedNovember 2011

Tracking Information[ + expand ][ + ]

First Received DateOctober 31, 2011
Last Updated DateNovember 3, 2011
Start DateMarch 2002
Estimated Primary Completion DateOctober 2004
Current Primary Outcome MeasuresChange of % HbA1c (glycosylated haemoglobin) in blood [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres [Designated as safety issue: No]
  • Incidence of clinical and/or biochemistry hypoglycaemia episodes [Designated as safety issue: No]
  • Incidence of adverse events [Designated as safety issue: No]
  • Presence of laboratory abnormalities in routine blood analyses [Designated as safety issue: No]
  • Change of the blood pressure and/or heart rate [Designated as safety issue: No]
  • Treatment compliance [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleComparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes
Official TitleMulticentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of
metformin and repaglinide used alone or combined administered as initial treatment in
subjects with type 2 diabetes in which diet and exercise have failed.
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: metformin
Adminstered orally during the three main meals for 24 weeks
Drug: repaglinide
Administered orally before the three main meals for 24 weeks
Study Arm (s)
  • Experimental: Met
  • Active Comparator: Rep
  • Active Comparator: Met+Rep

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment182
Estimated Completion DateOctober 2004
Estimated Primary Completion DateOctober 2004
Eligibility Criteria
Inclusion Criteria:

- Subjects with type 2 diabetes

- Treated by diet for at least 3 months

- Never treated with hypoglycaemic drugs

- HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%

Exclusion Criteria:

- Very symptomatic diabetes

- Advanced vascular complications

- Manifest renal failure

- Manifest hepatic disease

- Pregnancy, breast feeding or intention to become pregnant or if it is considered that
the patient is not using adequate contraceptive measures. Adequate contraceptive
measures are considered to be an intrauterine device, oral contraceptives and barrier
methods
GenderBoth
Ages35 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesSpain

Administrative Information[ + expand ][ + ]

NCT Number NCT01465152
Other Study ID NumbersAGEE-1411
Has Data Monitoring CommitteeNo
Information Provided ByNovo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators Study Director: Mónica Parramón Ponz Novo Nordisk Pharma SA
Verification DateNovember 2011

Locations[ + expand ][ + ]

Spain
Zaragoza, Spain, 50007