Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes

Novo Nordisk A/S1,976 enrolled

Overview

This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

Study Type

OBSERVATIONAL

Enrollment

1,976

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent obtained before any trial-related activities * Type 2 diabetes * HbA1c between 7-9% * Insulin naive * Inadequate control with oral antidiabetics therapy as judged by investigator Exclusion Criteria: * Patients with type 1 diabetes * Hypersensitivity to Levemir® or to any of the excipients * Pregnancy, or desire of pregnancy within next 6 months * HbA1c greater than or equal to 9% * Known or suspected allergy to the trial product or to any of the excipients * Subjects who are unlikely to comply with protocol

Locations (1)

Unnamed facility

Algiers, Algeria

Outcomes

Primary Outcomes

Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.

Time frame: During study

Secondary Outcomes

HbA1c

Time frame: after 12 weeks (3 months) AND after 24 weeks (6 months)

FBG (Fasting Blood Glucose)

Time frame: Monthly average for each month, and average of the past quarter

Weight

Time frame: after 12 weeks (3 months) AND after 24 weeks (6 months)

Data from ClinicalTrials.gov

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