Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: soluble human insulin; Drug: biphasic insulin aspart

• Registration Number: NCT00698126
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4099

Inclusion Criteria

• Patients with type 2 diabetes
• Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years

Exclusion Criteria

• Patients with an end-stage renal failure
• Patients with a serious liver disease
• Patients with concomitant malignant disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	soluble human insulin	-
B	biphasic insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Number of major hypoglycaemic events reported as serious adverse drug reactions	after 26 weeks

Secondary Outcome Measures

Name	Time	Method
Number of all major (daytime and nocturnal) hypoglycaemic events	during 26 weeks
Number of serious and non serious drug reactions	during 26 weeks
Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level	after 26 weeks
Number of major hypoglycaemic events related to omission of a meal after injection	during 26 weeks
Number of major hypoglycaemic events related to physical exercise of at least 30 min duration	during 26 weeks
Number of serious adverse event	during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit	after 26 weeks
Weight and waist circumference change	during 26 weeks
Quality of Life (QoL)	after 26 weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇹 Rome, Italy