Type 2 Diabetes MellitusNCT00232583
Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
A study testing Metformin, Insulin and Metfomin in people with Type 2 Diabetes Mellitus, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin, Insulin and Metfomin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern
Dallas, Texas, 75390
About this study
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.
Read the detailed 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin, Insulin, Metfomin, Pioglitazone, glyburide
- Keywords
- TYpe 2 diabetes mellitus, Newly diagnosed, Beta-cell function
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 1000mg/BID
InsulinDrug
Insulin Novolg 70/30 per protocol titration
MetfominDrug
Metformin 1000mg/BID
PioglitazoneDrug
Pioglitazone 45mg
glyburideDrug
Glyburide per protocol titration
| Study group | Role | What they receive |
|---|---|---|
| Metfomin and Insulin | Active comparator | Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration Receives: Drug: Metformin; Drug: Insulin |
| Metformin, Pioglitazone and Glyburide | Active comparator | Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration Receives: Drug: Metfomin; Drug: Pioglitazone; Drug: glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell Function - C-peptide AUC (Area Under the Curve)
C-peptide AUC during a 3-hours mixed meal challenge testing
Measured: 72 months
Secondary outcomes (16)
Insulin Sensitivity as Measure be Matsuda Index
C-peptide-based Matsuda index using following formula: Matsuda index = 500,00 / root square [(fasting c-peptide x fasting glucose x 333) x (average c-peptide 0-120 mins x average glucose 0-120 mins x 333). Higher the Matsuda index, better the insulin sensitivity.
Measured: 72 months
Bet-cell Function Measured by Disposition Index
Disposition index was measured by multiplying the insulin secretion (C-peptide AUC/C-peptide AUC glucose) by the Matsuda index. Disposition index reflects the beta-cell function adjusted for total body insulin sensitivity
Measured: 72 months
Weight
Body Weight
Measured: 72 months
Inflammatory Markers - hsCRP
Inflammatory markers - hsCRP (C reactive protein)
Measured: 72 months
Inflammatory Markers -Fibrinogen
Inflammatory markers - Fibrinogen
Measured: 72 months
Inflammatory Markers - PAI-1
Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)
Measured: 72 months
Quality of Life Survey (QoL) - Current Health Perception
Current health perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.
Measured: 72 months
Quality of Life Survey (QoL) - Treatment Satisfaction
Treatment satisfaction was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.
Measured: 72 months
Quality of Life Survey (QoL) - Treatment Impact
Treatment impact was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.
Measured: 72 months
Quality of Life Survey (QoL) - Social or Vocational Worry
Social or vocational worry was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.
Measured: 72 months
Quality of Life Survey (QoL) - Hypoglycemia Fear
Hypoglycemia fear was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry
Measured: 72 months
Quality of Life Survey (QoL) - Glycemia Control Perception
Glycemia control perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled.
Measured: 72 months
Quality of Life Survey (QoL) - Lifestyle Flexibility
Lifestyle flexibility was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.
Measured: 72 months
Quality of Life Survey (QoL) - Social Stigma
Social stigma was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1- strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.
Measured: 72 months
Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
Satisfaction with insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.
Measured: 72 months
Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
Willingness to continue insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startNov 2003
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ildiko Lingvay, University of Texas Southwestern Medical Center
- Investigators
- Philip Raskin, MD, Principal investigator, University of TexasIldiko Lingvay, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232583
- Sponsor's protocol ID
- 1003-623
- Status last verified
- Nov 2017
- First submitted
- 30 Sep 2005
- Last updated
- 14 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17362692Harrison 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.
PubMed 22723578Lingvay 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.
PubMed 19592630
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00232583
- Acronym / sponsor ID
- 1003-623
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- TYpe 2 diabetes mellitus, Newly diagnosed, Beta-cell function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Posted 28 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metfomin and Insulin | Active comparator | Drug: Metformin, Drug: InsulinMetformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration |
| Metformin, Pioglitazone and Glyburide | Active comparator | Drug: Metfomin, Drug: Pioglitazone, Drug: glyburideMetformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 1000mg/BID | Drug | Metfomin and Insulin |
| InsulinInsulin Novolg 70/30 per protocol titration | Drug | Metfomin and Insulin |
| MetfominMetformin 1000mg/BID | Drug | Metformin, Pioglitazone and Glyburide |
| PioglitazonePioglitazone 45mg | Drug | Metformin, Pioglitazone and Glyburide |
| glyburideGlyburide per protocol titration | Drug | Metformin, Pioglitazone and Glyburide |
Primary outcome
Beta-cell Function - C-peptide AUC (Area Under the Curve)
Time frame: 72 months
C-peptide AUC during a 3-hours mixed meal challenge testing
16 secondary outcomes
Insulin Sensitivity as Measure be Matsuda Index
Time frame: 72 months
Bet-cell Function Measured by Disposition Index
Time frame: 72 months
Weight
Time frame: 72 months
Inflammatory Markers - hsCRP
Time frame: 72 months
Inflammatory Markers -Fibrinogen
Time frame: 72 months
Inflammatory Markers - PAI-1
Time frame: 72 months
Quality of Life Survey (QoL) - Current Health Perception
Time frame: 72 months
Quality of Life Survey (QoL) - Treatment Satisfaction
Time frame: 72 months
Quality of Life Survey (QoL) - Treatment Impact
Time frame: 72 months
Quality of Life Survey (QoL) - Social or Vocational Worry
Time frame: 72 months
Quality of Life Survey (QoL) - Hypoglycemia Fear
Time frame: 72 months
Quality of Life Survey (QoL) - Glycemia Control Perception
Time frame: 72 months
Quality of Life Survey (QoL) - Lifestyle Flexibility
Time frame: 72 months
Quality of Life Survey (QoL) - Social Stigma
Time frame: 72 months
Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
Time frame: 72 months
Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
Time frame: 72 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17362692Lingvay 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.
- Derived from this study: PubMed 22723578Harrison 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.
- Derived from this study: PubMed 19592630Lingvay 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.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Raskin, MD principal investigator
University of Texas
Ildiko Lingvay, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin, Insulin and Metfomin in people with Type 2 Diabetes Mellitus, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-cell Function - C-peptide AUC (Area Under the Curve) (time frame: 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00232583, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.