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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metfomin and Insulin | Active Comparator | Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration |
|
| Metformin, Pioglitazone and Glyburide | Active Comparator | Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 1000mg/BID |
| |
| Insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-cell Function - C-peptide AUC (Area Under the Curve) | C-peptide AUC during a 3-hours mixed meal challenge testing | 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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.](streamdown:incomplete-link) | 72 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Raskin, MD | University of Texas | Principal Investigator |
| Ildiko Lingvay, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17362692 | Result | 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. | |
| 22723578 | Derived | 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. |
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A 3-months run-in period preceeded randomization. During this period all patients were treated with insulin and metformin.
Patients recruited at UT Southwestern Clinical Diabetes Research Office
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| ID | Title | Description |
|---|---|---|
| FG000 | Metfomin & Insulin | Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose). |
| FG001 | Metfomin, Pioglitazone & Glyburide | Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metfomin & Insulin | Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose). |
| BG001 | Metfomin, Pioglitazone & Glyburide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Beta-cell Function - C-peptide AUC (Area Under the Curve) | C-peptide AUC during a 3-hours mixed meal challenge testing | Posted | Mean | Standard Deviation | ng*min/mL | 72 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metfomin & Insulin | Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment | Cardiac arrest leading to sudden death. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI disturbance | Gastrointestinal disorders | Non-systematic Assessment | Gastrointestinal adverse events included the following conditions: nausea, diarrhea, flatulence and or vomiting. These events were not reported separately. |
Relatively small trial, but longest (6-year) follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ildiko Lingvay | UT Southwestern Medical Center | 214-648-2779 | ildiko.lingvay@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D007328 | Insulin |
| D000077205 | Pioglitazone |
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011384 |
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| Drug |
Insulin Novolg 70/30 per protocol titration |
|
| Metfomin | Drug | Metformin 1000mg/BID |
|
| Pioglitazone | Drug | Pioglitazone 45mg |
|
| glyburide | Drug | Glyburide per protocol titration |
|
| 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 |
| 72 months |
| Weight | Body Weight | 72 months |
| Inflammatory Markers - hsCRP | Inflammatory markers - hsCRP (C reactive protein) | 72 months |
| Inflammatory Markers -Fibrinogen | Inflammatory markers - Fibrinogen | 72 months |
| Inflammatory Markers - PAI-1 | Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1) | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 72 months |
| 19592630 | 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. |
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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.](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | index | 72 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | index | 72 months |
|
|
|
| Secondary | Weight | Body Weight | Posted | Mean | Standard Deviation | kg | 72 months |
|
|
|
| Secondary | Inflammatory Markers - hsCRP | Inflammatory markers - hsCRP (C reactive protein) | Posted | Mean | Standard Deviation | mg/L | 72 months |
|
|
|
| Secondary | Inflammatory Markers -Fibrinogen | Inflammatory markers - Fibrinogen | Posted | Mean | Standard Deviation | mg/dL | 72 months |
|
|
|
| Secondary | Inflammatory Markers - PAI-1 | Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1) | Posted | Mean | Standard Deviation | IU/L | 72 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a sale | 72 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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. | Data were not collected from participants in the "Metfomin, Pioglitazone & Glyburide" Arm/Group since patients did not receive insulin. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| Secondary | 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. | Data were not collected from participants in the "Metfomin, Pioglitazone & Glyburide" Arm/Group since patients did not receive insulin. | Posted | Mean | Standard Deviation | score on a scale | 72 months |
|
|
|
| 1 |
| 29 |
| 5 |
| 29 |
| EG001 | Metfomin, Pioglitazone & Glyburide | Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily). | 1 | 29 | 6 | 29 |
|
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| D004700 | Endocrine System Diseases |
| Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |