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| ID | Type | Description | Link |
|---|---|---|---|
| Sub-study 4 | Other Identifier | Merck Sharp & Dohme Corp. | |
| R01DK061644-09 | U.S. NIH Grant/Contract | View source |
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Per source documents the study was terminated well in advance of targeted enrollment. A method for the analysis of insulin and proinsulin samples was never fully developed and validated. Study terminated upon expiration of IRB approval
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.
We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Group | Experimental | Participants with Type 2 diabetes |
|
| Non-diabetic Group | Active Comparator | Participants who are non-diabetic will serve as control. treatment is matched to experimental group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucagon like peptide-1 | Drug | GLP-1 1 pmole/kg/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Biosynthesis Rate | Blood insulin biosynthesis rate | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel T Stein, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicinie | The Bronx | New York | 10461 | United States |
Of the 22 participants who provided informed consent for 1999-041 Substudy #4, 20 met inclusion/exclusion criteria and were enrolled and randomized into the study.
Recruitment of study participants across the range of 1999-041 studies occurred at the Albert Einstein College of Medicine beginning in November 2007. The first participant into 1999-041, Substudy #4 was enrolled during August 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic Group | Participants with Type 2 diabetes glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1 |
| FG001 | Non-diabetic Group | Participants who are non-diabetic will serve as control. treatment is matched to experimental group glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic Group | Participants with Type 2 diabetes glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1 |
| BG001 | Non-diabetic Group | Participants who are non-diabetic will serve as control. treatment is matched to experimental group glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Insulin Biosynthesis Rate | Blood insulin biosynthesis rate | Study was terminated early. The LC/MS assay being developed to optimize and validate the analysis of insulin and proinsulin biosynthesis samples was never completed and, as such, data were not collected. | Posted | 24 hours |
|
Participants were evaluated for adverse events during the course of each IV infusion date. Infusion dates took placed during study visits and were up to 4 full days in duration, scheduled up to 1 year based on availability
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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 | Diabetic Group | Participants with Type 2 diabetes glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Cramp (transient) | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Stein | Albert Einstein College of Medicine | 718-430-2237 | daniel.stein@einsteinmed.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D054795 | Incretins |
| D000085002 | Glycemic Control |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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| glucose control | Dietary Supplement | glucose without GLP-1 |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Non-diabetic Group | Participants who are non-diabetic will serve as control. treatment is matched to experimental group glucagon like peptide-1: GLP-1 1 pmole/kg/min glucose control: glucose without GLP-1 | 0 | 17 | 0 | 17 | 7 | 17 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Thighs/toes |
|
| Superficial Thrombophlebitis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Nodules |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Unconfirmed |
|
| Bruising | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Ecchymosis |
|
| Edema Limbs | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Left arm swelling |
|
| Injection Site Reaction | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Blistering adjacent to IV site |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013812 | Therapeutics |