Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2
Intervention: repaglinide (Drug); insulin NPH (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Per Knud Christensen, Study Director, Affiliation: Novo Nordisk A/S
Summary
This trial is conducted in Asia and South Africa. The aim of this trial is to compare the
efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn)
with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on
repaglinide.
Clinical Details
Official title: Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: HbA1c (glycosylated haemoglobin)
Secondary outcome: FPG (fasting plasma glucose)7-point blood glucose profile Hypoglycaemic episodes Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 2 diabetes
- HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
- BMI (body mass index) maximum 35 kg/m^2
Locations and Contacts
Hong Kong, Hong Kong
Kota Bharu, Kelantan 16150, Malaysia
Pasig City 1605, Philippines
Tainan 710, Taiwan
Pretoria, Gauteng, South Africa
Additional Information
Clinical Trials at Novo Nordisk
Starting date: June 2001
Last updated: March 23, 2012
|