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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin; Drug: repaglinide; Drug: isophane human insulin

• Registration Number: NCT01720303
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09-19
• Primary Completion: 2003-04-10
• Study Completion: 2003-04-10
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rep + NPH	isophane human insulin	-
Premixed insulin/NPH	insulin	-
Rep + NPH	repaglinide	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c

Secondary Outcome Measures

Name	Time	Method
Change in FBG (Fasting Blood Glucose)
Change in body weight

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Shanghai, Shanghai, China