Back to resultsComparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
repaglinide
biphasic human insulin 30
insulin NPH
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
Fasting blood glucose (FBG)
Incidence of hypoglycaemic episodes
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00799448
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment status
Study Start Date
September 16, 2003 (Actual)
Primary Completion Date
September 20, 2004 (Actual)
Study Completion Date
September 20, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
repaglinide
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin 30
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 20 weeks of treatment
Secondary Outcome Measure Information:
Title
Fasting blood glucose (FBG)
Title
Incidence of hypoglycaemic episodes
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
15127
Country
Greece
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this 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
We'll reach out to this number within 24 hrs