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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465152
• Other study ID #: AGEE-1411
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2011
• Last updated: February 17, 2017
• Start date: March 6, 2002
• Est. completion date: October 21, 2004

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 21, 2004
• Est. primary completion date: October 21, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• metformin
Adminstered orally during the three main meals for 24 weeks
• repaglinide
Administered orally before the three main meals for 24 weeks

Locations

Country	Name	City	State
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Benamargosa
Spain	Novo Nordisk Investigational Site	Burlada
Spain	Novo Nordisk Investigational Site	Camas
Spain	Novo Nordisk Investigational Site	Fuenlabrada
Spain	Novo Nordisk Investigational Site	Gijón
Spain	Novo Nordisk Investigational Site	Granada
Spain	Novo Nordisk Investigational Site	Lugo
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Portugalete
Spain	Novo Nordisk Investigational Site	San Adria del Besos
Spain	Novo Nordisk Investigational Site	Santander
Spain	Novo Nordisk Investigational Site	Santander
Spain	Novo Nordisk Investigational Site	Tegueste
Spain	Novo Nordisk Investigational Site	Valencia
Spain	Novo Nordisk Investigational Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of % HbA1c (glycosylated haemoglobin) in blood
Secondary	Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres
Secondary	Incidence of clinical and/or biochemistry hypoglycaemia episodes
Secondary	Incidence of adverse events
Secondary	Presence of laboratory abnormalities in routine blood analyses
Secondary	Change of the blood pressure and/or heart rate
Secondary	Treatment compliance

External Links

•   Clinical Trials at Novo Nordisk