Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication (A1chieve®)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00869908
First received: March 23, 2009
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin aspart
Drug: insulin detemir
Drug: biphasic insulin aspart

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in number of hypoglycaemic events [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in PPG (postprandial glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 66726
Study Start Date: November 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • NovoRapid®
  • ANA
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Drug: biphasic insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869908

  Show 22 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Praful Chakkarwar, MBBS, MD Novo Nordisk International Operations
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00869908     History of Changes
Other Study ID Numbers: INS-3693
Study First Received: March 23, 2009
Last Updated: July 13, 2012
Health Authority: Algeria: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Bangladesh: Drug Control Administration
China: Food and Drug Administration
Egypt: Ministry of Health and Population
India: Ministry of Health
Malaysia: Medical Research Ethics Committee (MREC)
Mexico: Federal Commission for Protection Against Health Risks
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Bureau of Pharmaceutical Affairs
Turkey: Ministry of Health
Jordan: Ministry of Health
Pakistan: Ministry of Health
Iran: Ministry of Health and Medical Education
Russia: Federal Ethics Committee
Indonesia: National Agency of Drug and Food Control
Morocco: Ministry of Health
Philippines: Bureau of Food and Drugs
Saudi Arabia: Food and Drug Administration
Tunisia: Department of Medicine and Pharmacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014