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An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00698269
First received: June 13, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: insulin detemir
Drug: biphasic insulin aspart 30
Drug: insulin aspart

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Incidence of major hypoglycaemic events reported [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in FPG [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in PPG [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in number of hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Number of adverse drug reactions (ADR) [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 5926
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: Levemir®
B Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
C Drug: 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:   Probability Sample
Study Population

A non-randomized sample of Type 1 or Type 2 diabetics

Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
  • Selection will be at the discretion of the individual physician

Exclusion Criteria:

  • Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
  • Previous enrolled in this study
  • Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698269

Locations
Saudi Arabia
Riyadh, Saudi Arabia, 3542
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Waleed AbdelFattah AbdelFattah, MD Novo Nordisk Pharma Gulf
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00698269     History of Changes
Other Study ID Numbers: INS-3532
Study First Received: June 13, 2008
Last Updated: July 12, 2012
Health Authority: Saudi Arabia: Ministry of Health
United Arab Emirates: Ministry of Health
Oman: Ministry of Health
Kuwait: Ministry of Health
Bahrain: Ministry of Health
Qatar: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013