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Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily (TITRATE™)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00634842
First Posted: March 13, 2008
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% [ Time Frame: week 20 ]
    Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment


Secondary Outcome Measures:
  • Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% [ Time Frame: week 20 ]
    Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment

  • Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline [ Time Frame: week -2, week 20 ]
    Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20

  • Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) [ Time Frame: weeks 0-20 ]

    Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:

    • If subject was unable to treat himself: Major incidence.
    • If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.
    • If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.


Enrollment: 244
Study Start Date: February 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FPG 70-90 mg/dL
Aggressive FPG (fasting plasma glucose) titration target range group
Drug: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
Experimental: FPG 80-110 mg/dL
Conventional FPG (fasting plasma glucose) titration target range group
Drug: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • 1-3 oral treatments
  • Insulin naive
  • BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria:

  • Pregnancy
  • Retinopathy
  • Cardiac disease
  • Uncontrolled hypertension
  • Recurrent hypoglycaemia
  Contacts and Locations
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): NCT00634842


  Show 69 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00634842     History of Changes
Other Study ID Numbers: NN304-3502
First Submitted: March 6, 2008
First Posted: March 13, 2008
Results First Submitted: October 23, 2009
Results First Posted: December 22, 2009
Last Update Posted: March 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs