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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00799448
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 12.2
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: repaglinide; Drug: biphasic human insulin 30; Drug: insulin NPH	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 16, 2003
• Actual Primary Completion Date: Sep 20, 2004
• Actual Study Completion Date: Sep 20, 2004

Outcome Measures

Primary Outcome Measures

1. HbA1c [after 20 weeks of treatment]

Secondary Outcome Measures

1. Fasting blood glucose (FBG) []

2. Incidence of hypoglycaemic episodes []

3. Adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Athens		Greece	15127

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00799448
• Other Study ID Numbers: AGEE-1524
• First Posted: Nov 27, 2008
• Last Update Posted: Feb 20, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin; Insulin, Globin Zinc; Repaglinide; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef

Study Results

No Results Posted as of Feb 20, 2017