N/A
N=58
Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00232583 ↗Enrolled (actual)
58
Serious AEs
3.5%
Results posted
May 2015
Primary outcome: Primary: Beta-cell Function - C-peptide AUC (Area Under the Curve) — 2096; 1725 ng*min/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Metformin (Drug); Insulin (Drug); Metfomin (Drug); Pioglitazone (Drug); glyburide (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beta-cell Function - C-peptide AUC (Area Under the Curve) |
2096; 1725 | — |
| SECONDARY Insulin Sensitivity as Measure be Matsuda Index |
3.12; 2.45 | — |
| SECONDARY Bet-cell Function Measured by Disposition Index |
0.12; 0.16 | — |
| SECONDARY Weight |
107.7; 107.9 | — |
| SECONDARY Inflammatory Markers - hsCRP |
6.9; 6.1 | — |
| SECONDARY Inflammatory Markers -Fibrinogen |
399.0; 395.4 | — |
| SECONDARY Inflammatory Markers - PAI-1 |
13.9; 16.7 | — |
| SECONDARY Quality of Life Survey (QoL) - Current Health Perception |
2.7; 2.9 | — |
| SECONDARY Quality of Life Survey (QoL) - Treatment Satisfaction |
1.7; 2.1 | — |
| SECONDARY Quality of Life Survey (QoL) - Treatment Impact |
1.7; 1.8 | — |
| SECONDARY Quality of Life Survey (QoL) - Social or Vocational Worry |
1.8; 1.7 | — |
| SECONDARY Quality of Life Survey (QoL) - Hypoglycemia Fear |
1.8; 1.8 | — |
| SECONDARY Quality of Life Survey (QoL) - Glycemia Control Perception |
2.8; 2.0 | — |
| SECONDARY Quality of Life Survey (QoL) - Lifestyle Flexibility |
2.1; 2.0 | — |
| SECONDARY Quality of Life Survey (QoL) - Social Stigma |
2.2; 2.2 | — |
| SECONDARY Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment |
1.2 | — |
| SECONDARY Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment |
1.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00232583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.