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

This study has been terminated.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00799448

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: repaglinide Drug: biphasic human insulin 30 Drug: insulin NPH	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin, isophane AG-EE 388 ZW

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting blood glucose (FBG) [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	September 2003
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799448

Locations

Greece

Athens, Greece, 15127

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

A. Tigga

Novo Nordisk Hellas Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	AGEE-1524
Study First Received:	November 26, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00799448
Health Authority:	Greece: National Organization of Medicines

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin
Repaglinide

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009