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The purpose of this study is to evaluate the degree of beta-cell dysfunction among participants with type 2 diabetes and the association between beta-cell dysfunction and demographic, clinical, and treatment variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Participants receiving routine care under a diabetologist. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years | HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. | Baseline and 4 years |
| Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years | Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion. | Baseline and Year 4 |
| Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio | HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Participants visiting a diabetologist as part of their routine care. Investigator's prescription is not influenced by the study: Investigator decides about what is the best treatment for any single participant independently of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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This observational study was conducted at 9 outpatient diabetes clinics in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants receiving routine care under a diabetologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants receiving routine care under a diabetologist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years | HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. | Participants who had laboratory parameters at Baseline and at Year 4. | Posted | Mean | Standard Deviation | Percentage of Beta Cell Function | Baseline and 4 years |
|
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There were no plans for the systematic collection or analysis of serious adverse events (SAEs) or adverse events (AEs) in the MK-0000-113 trial. Any SAEs or AEs reported were unsolicited and non-systematically assessed.
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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 | All Participants | Participants receiving routine care under a diabetologist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to parotid cancer in advanced stage [Salivary gland cancer] | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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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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| Lost to Follow-up |
|
| Laboratory parameters unavailable |
|
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years | Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion. | Participants who had laboratory parameters at Baseline and at Year 4. | Posted | Mean | Standard Deviation | PI/I | Baseline and Year 4 |
|
|
|
|
| Primary | Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio | HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion. | Participants with fasting plasma insulin and glucose concentration assessments at baseline. | Posted | Mean | Standard Deviation | Percentage Beta Cell Function | Baseline |
|
|
|
|
| 1 |
| 507 |
| 0 |
| 507 |
|
Each site can publish its own results without the results of other sites after the publication of the study or after 24 months from completion of publication. The author list will be established with the participating sites before the layout of the text to be published. The company will need to evaluate all the proposed summaries, manuscripts or presentations 60 days prior to publication. The revision made by Company could be accelerated in order to satisfy the guidelines concerning publication.
| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|
| IV PI/PII >1.355 |
|