Clinical trial NCT00869908: Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication
Official title: The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 66726
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only people with type 2 diabetes treated by general practitioners and specialists who prescribe insulin analogues in their routine practice will be included

Brief summary: This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion


Eligibility criteria: Inclusion Criteria:

* After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.
* The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

* Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.
* Subjects who were previously enrolled in this study.
* Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.

Primary outcomes:
measure: Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions
timeFrame: at baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice
timeFrame: at baseline, 12 weeks and 24 weeks
measure: Change in number of hypoglycaemic events
timeFrame: at baseline, 12 weeks and 24 weeks
measure: Change in HbA1c
timeFrame: at baseline, 12 weeks and 24 weeks
measure: Change in FPG (Fasting Plasma Glucose)
timeFrame: at baseline, 12 weeks and 24 weeks
measure: Change in PPG (postprandial glucose)
timeFrame: at baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Novo Nordisk Investigational Site
city: Prov. de Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Dhaka
country: Bangladesh
facility: Novo Nordisk Investigational Site
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Cairo
country: Egypt
facility: Novo Nordisk Investigational Site
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
city: Jakarta
country: Indonesia
facility: Novo Nordisk Investigational Site
city: Teheran
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Amman
country: Jordan
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Tripoli
country: Libyan Arab Jamahiriya
facility: Novo Nordisk Investigational Site
city: Selangor Darul Ehsan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
city: Casablanca
country: Morocco
facility: Novo Nordisk Investigational Site
city: Karachi
country: Pakistan
facility: Novo Nordisk Investigational Site
city: Manilla
country: Philippines
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Tunisia
country: Tunisia
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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