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NCT00634842 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— TITRATE™  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00634842
Other study ID # NN304-3502
Secondary ID
Status Completed
Phase Phase 4
First received March 6, 2008
Last updated June 26, 2012
Start date February 2008
Est. completion date October 2008

Study information
Verified date June 2012
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 244
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Puerto Rico Novo Nordisk Clinical Trial Call Center Rio Piedras
United States Novo Nordisk Clinical Trial Call Center Arlington Texas
United States Novo Nordisk Clinical Trial Call Center Artesia California
United States Novo Nordisk Clinical Trial Call Center Athens Georgia
United States Novo Nordisk Clinical Trial Call Center Berlin New Jersey
United States Novo Nordisk Clinical Trial Call Center Boca Raton Florida
United States Novo Nordisk Clinical Trial Call Center Camden New Jersey
United States Novo Nordisk Clinical Trial Call Center Chattanooga Tennessee
United States Novo Nordisk Clinical Trial Call Center Chattanooga Tennessee
United States Novo Nordisk Clinical Trial Call Center Chesterfield Missouri
United States Novo Nordisk Clinical Trial Call Center Chicago Illinois
United States Novo Nordisk Clinical Trial Call Center Clearwater Florida
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Dayton Ohio
United States Novo Nordisk Clinical Trial Call Center Dayton Ohio
United States Novo Nordisk Clinical Trial Call Center Escondido California
United States Novo Nordisk Clinical Trial Call Center Fullerton California
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center Idaho Falls Idaho
United States Novo Nordisk Clinical Trial Call Center Jacksonville Florida
United States Novo Nordisk Clinical Trial Call Center Jacksonville Florida
United States Novo Nordisk Clinical Trial Call Center Lake Mary Florida
United States Novo Nordisk Clinical Trial Call Center Lawrenceville New Jersey
United States Novo Nordisk Clinical Trial Call Center Mentor Ohio
United States Novo Nordisk Clinical Trial Call Center Midland Texas
United States Novo Nordisk Clinical Trial Call Center Milwaukee Wisconsin
United States Novo Nordisk Clinical Trial Call Center New York New York
United States Novo Nordisk Clinical Trial Call Center Norristown Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Odessa Texas
United States Novo Nordisk Clinical Trial Call Center Oklahoma City Oklahoma
United States Novo Nordisk Clinical Trial Call Center Omaha Nebraska
United States Novo Nordisk Clinical Trial Call Center Orange California
United States Novo Nordisk Clinical Trial Call Center Philadelphia Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Plantation Florida
United States Novo Nordisk Clinical Trial Call Center Prospect Connecticut
United States Novo Nordisk Clinical Trial Call Center Roswell Georgia
United States Novo Nordisk Clinical Trial Call Center Roswell Georgia
United States Novo Nordisk Clinical Trial Call Center San Antonio Texas
United States Novo Nordisk Clinical Trial Call Center Savannah Georgia
United States Novo Nordisk Clinical Trial Call Center Spartanburg South Carolina
United States Novo Nordisk Clinical Trial Call Center Spokane Washington
United States Novo Nordisk Clinical Trial Call Center Spring Valley California
United States Novo Nordisk Clinical Trial Call Center St. Louis Missouri
United States Novo Nordisk Clinical Trial Call Center St. Paul Minnesota
United States Novo Nordisk Clinical Trial Call Center Staten Island New York
United States Novo Nordisk Clinical Trial Call Center Terre Haute Indiana
United States Novo Nordisk Clinical Trial Call Center Tipton Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Topeka Kansas
United States Novo Nordisk Clinical Trial Call Center Walnut Creek California
United States Novo Nordisk Clinical Trial Call Center West Seneca New York

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment week 20 No
Secondary Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment week 20 No
Secondary Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20 week -2, week 20 No
Secondary Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) 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.		 weeks 0-20 No
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