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NCT01562561 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01562561
Other study ID # AGEE-1272
Secondary ID
Status Completed
Phase Phase 3
First received March 22, 2012
Last updated February 17, 2017
Start date June 1, 2001
Est. completion date December 20, 2002

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 213
Est. completion date December 20, 2002
Est. primary completion date December 20, 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Type 2 diabetes

- HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)

- BMI (body mass index) maximum 35 kg/m^2

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide
2 mg at each main meal
• insulin NPH
Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Locations
Country Name City State
Hong Kong Novo Nordisk Investigational Site Shatin, New Territories
Malaysia Novo Nordisk Investigational Site Kota Bharu, Kelantan
Philippines Novo Nordisk Investigational Site Marikina City
Philippines Novo Nordisk Investigational Site Pasig City
Philippines Novo Nordisk Investigational Site Quezon City
South Africa Novo Nordisk Investigational Site Alberton
South Africa Novo Nordisk Investigational Site Brits North West
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Pretoria Gauteng
Taiwan Novo Nordisk Investigational Site Tainan city

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Hong Kong,  Malaysia,  Philippines,  South Africa,  Taiwan, 

References & Publications (1)

Panelo A, Wing JR; AGEE-1272 Study Group.. Repaglinide/bedtime NPH insulin is comparable to twice-daily NPH insulin. Diabetes Care. 2005 Jul;28(7):1789-90. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (glycosylated haemoglobin) Week 0 (visit 5); week 26
Secondary FPG (fasting plasma glucose) Week 0 (visit 5); week 26
Secondary 7-point blood glucose profile Week 0 (visit 5); week 26
Secondary Hypoglycaemic episodes Week 0 (visit 5); week 26
Secondary Adverse events Week 0 (Visit 5); week 26
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