Clinical trial NCT00232583: Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Official title: Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: TYpe 2 diabetes mellitus
Newly diagnosed
Beta-cell function
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 58
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

Detailed description: This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus diagnosed within the prior 2 months
* HbA1c \> 7% at the time of inclusion
* willing to perform intensive diabetes management
* able to comply with treatment and follow-up regimen

Exclusion Criteria:

* HbA1c \> 8% at time of randomization
* creatinine \> 1.5 mg/dl
* liver function tests \> 3 times the upper limit of normal
* severe anemia
* severe proliferative retinopathy
* NYHA class III or IV heart failure
* active CAD or recent (within 6 months) MI
* pregnant, willing to get pregnant, or not willing to practice any contraceptive method
* non-english speaking
* active heavy alcohol or illicit drug users (within past 6 months)
* history of lactic acidosis

Primary outcomes:
measure: Beta-cell Function - C-peptide AUC (Area Under the Curve)
timeFrame: 72 months
Secondary outcomes:
measure: Insulin Sensitivity as Measure be Matsuda Index
timeFrame: 72 months
measure: Bet-cell Function Measured by Disposition Index
timeFrame: 72 months
measure: Weight
timeFrame: 72 months
measure: Inflammatory Markers - hsCRP
timeFrame: 72 months
measure: Inflammatory Markers -Fibrinogen
timeFrame: 72 months
measure: Inflammatory Markers - PAI-1
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Current Health Perception
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Treatment Satisfaction
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Treatment Impact
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Social or Vocational Worry
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Hypoglycemia Fear
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Glycemia Control Perception
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Lifestyle Flexibility
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Social Stigma
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
timeFrame: 72 months
measure: Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
timeFrame: 72 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Texas
name: Philip Raskin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Ildiko Lingvay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lingvay I, Kaloyanova PF, Adams-Huet B, Salinas K, Raskin P. Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted. J Investig Med. 2007 Mar;55(2):62-8. doi: 10.2310/6650.2007.06036.
citation: Harrison LB, Adams-Huet B, Raskin P, Lingvay I. beta-cell function preservation after 3.5 years of intensive diabetes therapy. Diabetes Care. 2012 Jul;35(7):1406-12. doi: 10.2337/dc11-2170.
citation: Lingvay I, Legendre JL, Kaloyanova PF, Zhang S, Adams-Huet B, Raskin P. Insulin-based versus triple oral therapy for newly diagnosed type 2 diabetes: which is better? Diabetes Care. 2009 Oct;32(10):1789-95. doi: 10.2337/dc09-0653. Epub 2009 Jul 10.