An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

Novo Nordisk A/S5,926 enrolled

Overview

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

Study Type

OBSERVATIONAL

Enrollment

5,926

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

biphasic insulin aspart 30DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

insulin aspartDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetes * Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid® * Selection will be at the discretion of the individual physician Exclusion Criteria: * Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid® * Previous enrolled in this study * Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Locations (1)

Novo Nordisk Investigational Site

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Incidence of major hypoglycaemic events reported

Time frame: during 24 weeks of treatment

Change in HbA1c

Time frame: during 24 weeks of treatment

Secondary Outcomes

Percentage of subjects achieving HbA1c below 7.0%

Time frame: at 12 & 24 weeks

Change in FPG

Time frame: at 12 & 24 weeks

Change in PPG

Time frame: at 12 & 24 weeks

Body weight

Time frame: at 12 & 24 weeks

Change in number of hypoglycaemic events in the last 4 weeks before routine visits

Time frame: at 12 & 24 weeks

Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits

Time frame: at 12 & 24 weeks

Number of adverse drug reactions (ADR)

Time frame: at 12 & 24 weeks

Data from ClinicalTrials.gov

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