Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

The University of Texas System (UT)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone; Drug: Insulin; Drug: glyburide; Drug: Metformin; Drug: Metfomin

Study type: Interventional

Funder types: Other

Identifiers

NCT00232583

1003-623

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Metfomin and Insulin

Active Comparator group

Description:

Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration

Treatment:

Drug: Metformin

Drug: Insulin

Metformin, Pioglitazone and Glyburide

Active Comparator group

Description:

Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration

Treatment:

Drug: Metfomin

Drug: Pioglitazone

Drug: glyburide