Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus (START)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00687284
First received: May 27, 2008
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in glycaemic control as measured by HbA1c. [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5% [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • The effect on glycaemic control as measured by FPG [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in waist and hip perimeter [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 2188
Study Start Date: February 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (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®

  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetes mellitus type 2

Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes
  • Patients inadequately controlled by OAD
  • Patients willing to sign informed consent
  • Selection of study participants at the discretion of the physician
  • Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
  • Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months
  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: NCT00687284

Locations
Slovakia
Kosice, Slovakia, 040 01
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jozef Lacka, M.D. , CSc. Novo Nordisk Slovakia, s.r.o
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00687284     History of Changes
Other Study ID Numbers: NN304-3515
Study First Received: May 27, 2008
Last Updated: June 26, 2012
Health Authority: Slovakia: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on July 20, 2014