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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00715780
First received: July 14, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention
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
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of major hypoglycaemic episodes [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency and type of hypoglycaemic episodes [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse events [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse drug reactions [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]
  • Change in HbA1c from baseline [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
  • Change in PPG from baseline [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
  • Change in FPG from baseline [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
  • Subjects' insulin treatment satisfaction [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
  • Physicians' satisfaction with insulin therapy [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
  • Weight change [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Percentage of patients reaching the target of HbA1c less than 7.5% [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Percentage of patients reaching the target of HbA1c less than 7% [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Percentage of patients reaching the target of HbA1c less than 6.5% [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 1667
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00715780

Locations
Indonesia
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Sri I Soetomo, MD Novo Nordisk Indonesia
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00715780     History of Changes
Other Study ID Numbers: INS-3615
Study First Received: July 14, 2008
Last Updated: August 12, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Hypoglycemic Agents
Insulin, Isophane
Insulin Aspart
Biphasic Insulins
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014