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NCT01720303 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01720303
Other study ID # AGEE-3020
Secondary ID
Status Completed
Phase Phase 4
First received October 31, 2012
Last updated February 17, 2017
Start date September 19, 2002
Est. completion date April 10, 2003

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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 159
Est. completion date April 10, 2003
Est. primary completion date April 10, 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide
2 mg (tablets) before each main meal
• isophane human insulin
Injection s.c. (under the skin) at bedtime
• insulin
Injection s.c. (under the skin) twice daily

Locations
Country Name City State
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Shanghai Shanghai

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

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c
Secondary Change in FBG (Fasting Blood Glucose)
Secondary Change in body weight
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