Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01562561

Collaborator

(none)

213

Enrollment

Locations

Arms

18.6

Actual Duration (Months)

17.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: repaglinide Drug: insulin NPH	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

213 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Dec 20, 2002

Actual Study Completion Date :

Dec 20, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rep + NPH	Drug: repaglinide 2 mg at each main meal Drug: insulin NPH Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.
Active Comparator: NPH	Drug: insulin NPH Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Arm

Intervention/Treatment

Experimental: Rep + NPH

Drug: repaglinide

2 mg at each main meal

Drug: insulin NPH

Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Active Comparator: NPH

Drug: insulin NPH

Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Outcome Measures

Primary Outcome Measures

HbA1c (glycosylated haemoglobin) [Week 0 (visit 5); week 26]

Secondary Outcome Measures

FPG (fasting plasma glucose) [Week 0 (visit 5); week 26]
7-point blood glucose profile [Week 0 (visit 5); week 26]
Hypoglycaemic episodes [Week 0 (visit 5); week 26]
Adverse events [Week 0 (Visit 5); week 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetes
HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
BMI (body mass index) maximum 35 kg/m^2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Shatin, New Territories		Hong Kong
2	Novo Nordisk Investigational Site	Kota Bharu, Kelantan		Malaysia	16150
3	Novo Nordisk Investigational Site	Marikina City		Philippines	1800
4	Novo Nordisk Investigational Site	Pasig City		Philippines	1605
5	Novo Nordisk Investigational Site	Quezon City		Philippines	1100
6	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2193
7	Novo Nordisk Investigational Site	Pretoria	Gauteng	South Africa
8	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4001
9	Novo Nordisk Investigational Site	Brits	North West	South Africa	0250
10	Novo Nordisk Investigational Site	Cape Town	Western Cape	South Africa	7460
11	Novo Nordisk Investigational Site	Alberton		South Africa	1449
12	Novo Nordisk Investigational Site	Tainan city		Taiwan	710