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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®)

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ClinicalTrials.gov Identifier: NCT00869908
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin aspart Drug: insulin detemir Drug: biphasic insulin aspart

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Study Type : Observational
Actual Enrollment : 66726 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice [ Time Frame: at baseline, 12 weeks and 24 weeks ]
  2. Change in number of hypoglycaemic events [ Time Frame: at baseline, 12 weeks and 24 weeks ]
  3. Change in HbA1c [ Time Frame: at baseline, 12 weeks and 24 weeks ]
  4. Change in FPG (Fasting Plasma Glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ]
  5. Change in PPG (postprandial glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869908


Locations
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Algeria
Novo Nordisk Investigational Site
Algiers, Algeria, 16035
Argentina
Novo Nordisk Investigational Site
Prov. de Buenos Aires, Argentina, B1636DSU
Bangladesh
Novo Nordisk Investigational Site
Dhaka, Bangladesh, 1206
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100004
Egypt
Novo Nordisk Investigational Site
Cairo, Egypt
India
Novo Nordisk Investigational Site
Bangalore, India, 560001
Indonesia
Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520
Iran, Islamic Republic of
Novo Nordisk Investigational Site
Teheran, Iran, Islamic Republic of
Jordan
Novo Nordisk Investigational Site
Amman, Jordan, 11844
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
Libyan Arab Jamahiriya
Novo Nordisk Investigational Site
Tripoli, Libyan Arab Jamahiriya
Malaysia
Novo Nordisk Investigational Site
Selangor Darul Ehsan, Malaysia
Mexico
Novo Nordisk Investigational Site
Mexico City, Mexico
Morocco
Novo Nordisk Investigational Site
Casablanca, Morocco, 20000
Pakistan
Novo Nordisk Investigational Site
Karachi, Pakistan
Philippines
Novo Nordisk Investigational Site
Manilla, Philippines, 1605
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119330
Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 307684
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan
Tunisia
Novo Nordisk Investigational Site
Tunisia, Tunisia, 1053
Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 34335
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00869908    
Other Study ID Numbers: INS-3693
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Insulin Detemir
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs