Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— PREDICTIVE™  

Official title:

Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264901
• Other study ID #: NN304-1720
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2005
• Last updated: January 30, 2017
• Start date: October 2005
• Est. completion date: November 2006

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5652
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months;

• BMI <= 45.0 kg/m2

• Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator

Exclusion Criteria:

• Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.

• Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months.

• Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues

• Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Plainsboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bhargava A, Chan V, Kimball ES, Oyer DS. Effects of Age on Glycemic Control in Patients With Type 2 Diabetes Treated with Insulin Detemir: A Post-Hoc Analysis of the PREDICTIVE™ 303 Study. Drugs Aging. 2016 Feb;33(2):135-41. doi: 10.1007/s40266-016-0342-9 — View Citation

Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 — View Citation

Selam JL, Koenen C, Weng W, Meneghini L. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin naïve patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study. Curr Med Res Opin. 2008 Jan;24(1):11-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the change from baseline to end of treatment		after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group
Secondary	Spontaneously reported adverse events during the trial
Secondary	Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)
Secondary	FPG during the trial (central laboratory) at Visit 2 and Visit 3
Secondary	Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3
Secondary	Insulin detemir doses at Visit 2 and Visit 3
Secondary	Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3

External Links

•   Clinical Trials at Novo Nordisk