Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00624364
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Type 2 diabetes
• Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
• Body mass index (BMI) below 40.0 kg/m2
• HbA1c between 7.5-13.0%

Exclusion Criteria

• History of drug or alcohol dependence
• Mental incapacity, unwillingness or language barriers precluding adequate
• Subjects previously screened to participation or having already participated in this trial
• Receipt of any investigational drug within the last month prior to this trial
• Known or suspected allergy to trial products or related products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Plasma glucose profiles
Cardiovascular risk factors
Incidence of hypoglycaemic episodes
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇿🇦 Richards Bay, South Africa