Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Beta-cell Function - C-peptide AUC (Area Under the Curve)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Ildiko Lingvay
MD, MPH, MSCS
University of Texas Southwestern Medical Center
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)
Arms & Interventions
Metfomin and Insulin
Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration
Intervention: Metformin
Metfomin and Insulin
Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration
Intervention: Insulin
Metformin, Pioglitazone and Glyburide
Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
Intervention: Metfomin
Metformin, Pioglitazone and Glyburide
Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
Intervention: Pioglitazone
Metformin, Pioglitazone and Glyburide
Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
Intervention: glyburide
Outcomes
Primary Outcomes
Beta-cell Function - C-peptide AUC (Area Under the Curve)
Time Frame: 72 months
C-peptide AUC during a 3-hours mixed meal challenge testing
Secondary Outcomes
- Insulin Sensitivity as Measure be Matsuda Index(72 months)
- Bet-cell Function Measured by Disposition Index(72 months)
- Inflammatory Markers - PAI-1(72 months)
- Inflammatory Markers - hsCRP(72 months)
- Quality of Life Survey (QoL) - Hypoglycemia Fear(72 months)
- Weight(72 months)
- Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment(72 months)
- Inflammatory Markers -Fibrinogen(72 months)
- Quality of Life Survey (QoL) - Treatment Satisfaction(72 months)
- Quality of Life Survey (QoL) - Treatment Impact(72 months)
- Quality of Life Survey (QoL) - Glycemia Control Perception(72 months)
- Quality of Life Survey (QoL) - Social Stigma(72 months)
- Quality of Life Survey (QoL) - Current Health Perception(72 months)
- Quality of Life Survey (QoL) - Social or Vocational Worry(72 months)
- Quality of Life Survey (QoL) - Lifestyle Flexibility(72 months)
- Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment(72 months)