CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Metformin +4 moredrug
Likely dose
Metformin 1000 mg twice daily, with insulin, pioglitazone 45 mg, or glyburide titrated per protocolAI-extracted
Key inclusion· 4
  • ✓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
Key exclusion· 9
  • ✕HbA1c >8% at time of randomization
  • ✕Creatinine >1.5 mg/dL
  • ✕Liver function tests >3 times upper limit of normal
  • ✕Severe anemia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00232583
NCT00232583N/ACompleted
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Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

University of Texas Southwestern Medical Center·interventional·Posted Oct 4, 2005·Updated Dec 14, 2017

In Brief

A clinical study evaluating Metformin, Insulin, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartNov 1, 2003
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 20.7 years ago

Interventions

Metformindrug

Metformin 1000mg/BID

Insulindrug

Insulin Novolg 70/30 per protocol titration

Metfomindrug

Metformin 1000mg/BID

Pioglitazonedrug

Pioglitazone 45mg

glyburidedrug

Glyburide per protocol titration