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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01720303

Collaborator

(none)

159

Enrollment

Locations

Arms

6.7

Actual Duration (Months)

Patients Per Site

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: repaglinide Drug: isophane human insulin Drug: insulin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy

Actual Study Start Date :

Sep 19, 2002

Actual Primary Completion Date :

Apr 10, 2003

Actual Study Completion Date :

Apr 10, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rep + NPH	Drug: repaglinide 2 mg (tablets) before each main meal Drug: isophane human insulin Injection s.c. (under the skin) at bedtime
Active Comparator: Premixed insulin/NPH	Drug: insulin Injection s.c. (under the skin) twice daily

Arm

Intervention/Treatment

Experimental: Rep + NPH

Drug: repaglinide

2 mg (tablets) before each main meal

Drug: isophane human insulin

Injection s.c. (under the skin) at bedtime

Active Comparator: Premixed insulin/NPH

Drug: insulin

Injection s.c. (under the skin) twice daily

Outcome Measures

Primary Outcome Measures

Change in HbA1c []

Secondary Outcome Measures

Change in FBG (Fasting Blood Glucose) []
Change in body weight []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

HbA1c between 7.5 % and 13.0% (both inclusive)
Fasting C-peptide above or equal to 0.33 nmol/l
BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

Exclusion Criteria:

Medical history of treatment with insulin within the last 6 months
Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Beijing	Beijing	China	100101
2	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	200040
3	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	200433