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No sufficient numbers of eligible participants
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This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | A regimen with traditional drugs only |
|
| Incretin-based Treatment | Experimental | A regimen including incretin-based drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Treatment | Drug | traditional drugs only |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Glycemic Target (HbA1c <7.5%). | Data not analyzed due to n=1 each arm. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Hypoglycemia Measured by Glucose Meter | Data not analyzed due to n=1 each arm. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Quality of Life | Data not analyzed due to n=1 each arm | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsin-Chieh Yeh, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay West Endocrinology Associates | Baltimore | Maryland | 21204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | A regimen with traditional drugs only Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only |
| FG001 | Incretin-based Treatment | A regimen including incretin-based drugs Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | A regimen with traditional drugs only Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only |
| BG001 | Incretin-based Treatment |
| 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 | Time to Achieve Glycemic Target (HbA1c <7.5%). | Data not analyzed due to n=1 each arm. | Data not analyzed due to n=1 each arm. | Posted | 6 months |
|
6 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 | Standard Treatment | A regimen with traditional drugs only Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hsin-Chieh Yeh | Johns Hopkins University | 410-614-4316 | hyeh1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2013 | Jan 12, 2018 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D007328 | Insulin |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Incretin-Based Treatment | Drug | incretin-based drugs |
|
|
A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | Overall Hypoglycemia Measured by Glucose Meter | Data not analyzed due to n=1 each arm. | Data not analyzed due to n=1 each arm. | Posted | 6 months |
|
|
| Other Pre-specified | Diabetes Quality of Life | Data not analyzed due to n=1 each arm | Data not analyzed due to n=1 each arm | Posted | 6 months |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Incretin-based Treatment | A regimen including incretin-based drugs Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs | 0 | 1 | 0 | 1 | 0 | 1 |
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |