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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

Page last updated: August 23, 2015

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