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Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

NCT ID: NCT00232583

Last Updated: 2017-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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TYpe 2 diabetes mellitus Newly diagnosed Beta-cell function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metfomin and Insulin

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 1000mg/BID

Insulin

Intervention Type DRUG

Insulin Novolg 70/30 per protocol titration

Metformin, Pioglitazone and Glyburide

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

Group Type ACTIVE_COMPARATOR

Metfomin

Intervention Type DRUG

Metformin 1000mg/BID

Pioglitazone

Intervention Type DRUG

Pioglitazone 45mg

glyburide

Intervention Type DRUG

Glyburide per protocol titration

Interventions

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Metformin

Metformin 1000mg/BID

Intervention Type DRUG

Insulin

Insulin Novolg 70/30 per protocol titration

Intervention Type DRUG

Metfomin

Metformin 1000mg/BID

Intervention Type DRUG

Pioglitazone

Pioglitazone 45mg

Intervention Type DRUG

glyburide

Glyburide per protocol titration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ildiko Lingvay

MD, MPH, MSCS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Raskin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Ildiko Lingvay, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Southwestern

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Lingvay I, Kaloyanova PF, Adams-Huet B, Salinas K, Raskin P. Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted. J Investig Med. 2007 Mar;55(2):62-8. doi: 10.2310/6650.2007.06036.

Reference Type RESULT
PMID: 17362692 (View on PubMed)

Harrison LB, Adams-Huet B, Raskin P, Lingvay I. beta-cell function preservation after 3.5 years of intensive diabetes therapy. Diabetes Care. 2012 Jul;35(7):1406-12. doi: 10.2337/dc11-2170.

Reference Type DERIVED
PMID: 22723578 (View on PubMed)

Lingvay I, Legendre JL, Kaloyanova PF, Zhang S, Adams-Huet B, Raskin P. Insulin-based versus triple oral therapy for newly diagnosed type 2 diabetes: which is better? Diabetes Care. 2009 Oct;32(10):1789-95. doi: 10.2337/dc09-0653. Epub 2009 Jul 10.

Reference Type DERIVED
PMID: 19592630 (View on PubMed)

Other Identifiers

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1003-623

Identifier Type: -

Identifier Source: org_study_id