Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

NCT00232583 | Completed Results

• 1 other identifier: 1003-623
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

TYpe 2 diabetes mellitus; Newly diagnosed; Beta-cell function

Outcome Measures

Primary Outcomes (1)

• Beta-cell Function - C-peptide AUC (Area Under the Curve)

  C-peptide AUC during a 3-hours mixed meal challenge testing

  72 months

Secondary Outcomes (16)

• Insulin Sensitivity as Measure be Matsuda Index

  72 months

• Bet-cell Function Measured by Disposition Index

  72 months

• Weight

  72 months

• Inflammatory Markers - hsCRP

  72 months

• Inflammatory Markers -Fibrinogen

  72 months

Study Arms (2)

Metfomin and Insulin

ACTIVE COMPARATOR

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

Drug: Metformin; Drug: Insulin

Metformin, Pioglitazone and Glyburide

ACTIVE COMPARATOR

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

Drug: Metfomin; Drug: Pioglitazone; Drug: glyburide

Interventions

Metformin DRUG

Metformin 1000mg/BID

Metfomin and Insulin

Insulin DRUG

Insulin Novolg 70/30 per protocol titration

Metfomin and Insulin

Metfomin DRUG

Metformin 1000mg/BID

Metformin, Pioglitazone and Glyburide

Pioglitazone DRUG

Pioglitazone 45mg

Metformin, Pioglitazone and Glyburide

glyburide DRUG

Glyburide per protocol titration

Metformin, Pioglitazone and Glyburide

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes mellitus diagnosed within the prior 2 months
• willing to perform intensive diabetes management
• able to comply with treatment and follow-up regimen

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (3)

• 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.

  PMID: 17362692 RESULT

• 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.

  PMID: 22723578 DERIVED

• 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.

  PMID: 19592630 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Insulin; Pioglitazone; Glyburide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonylurea Compounds; Urea; Amides; Sulfones

Limitations and Caveats

Relatively small trial, but longest (6-year) follow-up.

Results Point of Contact

• Title: Ildiko Lingvay
• Organization: UT Southwestern Medical Center

ildiko.lingvay@utsouthwestern.edu

214-648-2779

Study Officials

• Philip Raskin, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Ildiko Lingvay, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, MSCS

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: November 1, 2003
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 14, 2017
• Results First Posted: May 28, 2015

Record last verified: 2017-11

Locations

US (1)