Clinical trial NCT00264901: Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-12-13
Enrollment: 5652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the change from baseline to end of treatment
timeFrame: after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group
Secondary outcomes:
measure: Spontaneously reported adverse events during the trial
measure: Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)
measure: FPG during the trial (central laboratory) at Visit 2 and Visit 3
measure: Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3
measure: Insulin detemir doses at Visit 2 and Visit 3
measure: Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x.
citation: Selam JL, Koenen C, Weng W, Meneghini L. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin naive patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study. Curr Med Res Opin. 2008 Jan;24(1):11-20. doi: 10.1185/030079908x242755.
citation: 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.