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Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00771680
First received: October 9, 2008
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.

Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: biphasic insulin aspart 30
Drug: insulin aspart

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: at baseline visit and during 3, 6, 9 and 12 months ]
  • Serious adverse drug reactions including major hypoglycaemic events [ Time Frame: during 12 months of treatment ]

Secondary Outcome Measures:
  • Number of serious adverse drug reactions [ Time Frame: during 12 months of treatment ]
  • Number of all major (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ]
  • Number of all minor (daytime and nocturnal) hypoglycaemic events [ Time Frame: During 4 weeks prior to each study visit ]
  • Weight (BMI) change [ Time Frame: At 6 and 12 months ]
  • Variability in fasting blood glucose values and average (mean) fasting blood glucose level [ Time Frame: At baseline visit and after 6 and 12 months treatment ]
  • Average post-prandial blood glucose level (2h after dinner) [ Time Frame: At baseline visit and after 6 and 12 months treatment ]
  • Quality of Life (QoL) as assessed by patient questionnaire [ Time Frame: At baseline and the end of 6 and 12 months treatment ]

Enrollment: 10408
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Start dose and frequency at the discretion of the physician following clinical practice
Drug: biphasic insulin aspart 30
Start dose and frequency at the discretion of the physician following clinical practice
Drug: insulin aspart
Start dose and frequency at the discretion of the physician following clinical practice

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of both genders who, in practice settings, have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.
Criteria

Inclusion Criteria:

  • Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion Criteria:

  • In accordance with approved label
  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: NCT00771680

Locations
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119330
Ukraine
Novo Nordisk Investigational Site
Kiev, Ukraine, 252030
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00771680     History of Changes
Other Study ID Numbers: INS-3655
Study First Received: October 9, 2008
Last Updated: October 26, 2016

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, Isophane
Biphasic Insulins
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2017