NCT01465152|CompletedPhase 4

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

Multicentre, 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

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

AGEE-1411

Study Type

interventional

Target

182

Locations

1 country

Sites

Timeline

RegisteredNov 2011

StartedMar 2002

CompletionOct 2004

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

182

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline

Completed

Started Mar 2002

Typical duration for phase_4 diabetes

Geographic Reach

1 country

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

March 6, 2002

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2004

Completed

7 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed

Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

October 31, 2011

Last Update Submit

February 17, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change of % HbA1c (glycosylated haemoglobin) in blood

Secondary Outcomes (6)

Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres
Incidence of clinical and/or biochemistry hypoglycaemia episodes
Incidence of adverse events
Presence of laboratory abnormalities in routine blood analyses
Change of the blood pressure and/or heart rate
+1 more secondary outcomes

Study Arms (3)

Met

EXPERIMENTAL

Drug: metformin

Rep

ACTIVE COMPARATOR

Drug: repaglinide

Met+Rep

ACTIVE COMPARATOR

Drug: metforminDrug: repaglinide

Interventions

metforminDRUG

Adminstered orally during the three main meals for 24 weeks

MetMet+Rep

repaglinideDRUG

Administered orally before the three main meals for 24 weeks

Met+RepRep

Eligibility Criteria

Age35 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects with type 2 diabetes
Treated by diet for at least 3 months
Never treated with hypoglycaemic drugs

You may not qualify if:

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

Contact the study team to confirm eligibility.