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NCT00799448 Clinical Trial

Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00799448
Other study ID # AGEE-1524
Secondary ID
Status Terminated
Phase Phase 4
First received November 26, 2008
Last updated February 17, 2017
Start date September 16, 2003
Est. completion date September 20, 2004

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

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date September 20, 2004
Est. primary completion date September 20, 2004
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- HbA1c: 7.5-11.0% on current therapy

- OHA (oral hypoglycaemic agent) treatment for a minimum of two years

- BMI (body mass index): 25-32 kg/m2

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide

• biphasic human insulin 30

• insulin NPH

Locations
Country Name City State
Greece Novo Nordisk Investigational Site Athens

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 20 weeks of treatment
Secondary Fasting blood glucose (FBG)
Secondary Incidence of hypoglycaemic episodes
Secondary Adverse events
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