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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00634842
First received: March 6, 2008
Last updated: June 26, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634842

  Show 52 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Markus J. Merilainen, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00634842     History of Changes
Other Study ID Numbers: NN304-3502
Study First Received: March 6, 2008
Results First Received: October 23, 2009
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014