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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00869908
First received: March 23, 2009
Last updated: January 18, 2017
Last verified: January 2017
  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 ]

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 ]
  • Change in number of hypoglycaemic events [ Time Frame: at baseline, 12 weeks and 24 weeks ]
  • Change in HbA1c [ Time Frame: at baseline, 12 weeks and 24 weeks ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ]
  • Change in PPG (postprandial glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ]

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: January 18, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Biphasic Insulins
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2017