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Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

The University of Texas System (UT) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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