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Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents

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ClinicalTrials.gov Identifier: NCT00715780
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.

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

Study Type : Observational
Actual Enrollment : 1667 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents
Study Start Date : June 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: soluble human insulin
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: Actrapid®
Drug: biphasic human insulin
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Drug: insulin NPH
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Drug: insulin aspart
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
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation



Primary Outcome Measures :
  1. Incidence of major hypoglycaemic episodes [ Time Frame: during 26 weeks of insulin therapy ]

Secondary Outcome Measures :
  1. Frequency and type of hypoglycaemic episodes [ Time Frame: during 26 weeks of insulin therapy ]
  2. Frequency and type of adverse events [ Time Frame: during 26 weeks of insulin therapy ]
  3. Frequency and type of adverse drug reactions [ Time Frame: during 26 weeks of insulin therapy ]
  4. Change in HbA1c from baseline [ Time Frame: during 26 weeks of insulin therapy ]
  5. Change in PPG from baseline [ Time Frame: during 26 weeks of insulin therapy ]
  6. Change in FPG from baseline [ Time Frame: during 26 weeks of insulin therapy ]
  7. Subjects' insulin treatment satisfaction [ Time Frame: during 26 weeks of insulin therapy ]
  8. Physicians' satisfaction with insulin therapy [ Time Frame: during 26 weeks of insulin therapy ]
  9. Weight change [ Time Frame: at the end of the study ]
  10. Percentage of patients reaching the target of HbA1c less than 7.5% [ Time Frame: at the end of the study ]
  11. Percentage of patients reaching the target of HbA1c less than 7% [ Time Frame: at the end of the study ]
  12. Percentage of patients reaching the target of HbA1c less than 6.5% [ Time Frame: at the end of the study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 diabetic patients
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
  • Insulin naive
  • Poor glycaemic control on OADs and decided by the physician to start insulin therapy

Exclusion Criteria:

  • Type 1 diabetes patients
  • Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
  • Patients with a hypersensitivity to insulin or to any of the excipients
  • Patient groups not approved in the product label

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): NCT00715780


Locations
Indonesia
Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00715780     History of Changes
Other Study ID Numbers: INS-3615
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 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
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Biphasic Insulins
Hypoglycemic Agents
Isophane Insulin, Human
Insulin, Isophane
Physiological Effects of Drugs