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| Name | Class |
|---|---|
| Amylin Pharmaceuticals, LLC. | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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This study will look at whether or not the medication exenatide improves signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy.
This study will look at the effects of the medication exenatide on peripheral neuropathy in people with type 2 diabetes. Exenatide (trade name, BYETTA®) is an injectable medication used by people with type 2 diabetes to control blood sugar. Peripheral neuropathy is a complication of diabetes that can cause symptoms such as numbness, tingling or burning sensations in the feet and hands. Controlling blood sugars levels in type 2 diabetes is thought to prevent, delay or improve the damage to the nerve fibers that causes peripheral neuropathy. There is also some evidence that exenatide may have additional beneficial effects on the peripheral nerves, beyond the benefits of blood sugar control alone. In this study, about half of the participants will take exenatide by injection twice daily and the other half will take insulin glargine (Lantus®) by injection once daily. Both groups are expected to have similar improvement in blood sugar control. This study will show whether exenatide has beneficial effects on neuropathy beyond the benefits of better blood sugar control alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | Subjects will take exenatide by subcutaneous injection twice daily for 18 months |
|
| glargine | Active Comparator | Subjects will take 1 daily injection of insulin glargine for 18 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Clinical Neuropathy (CCN) | CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude < 5 μV and a conduction velocity < 40 m/sec for the sural nerve and an amplitude < 2.5 μV and a conduction velocity < 40 m/sec for the peroneal nerve). | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Autonomic Neuropathy (CAN) | Group differences in E/I ratio, a measure of cardiac autonomic function. | 18 months |
| Cardiac Autonomic Neuropathy | resting heart rate as marker of autonomic function at rest |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-epidermal Nerve Fiber Density | Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodica Pop-Busui, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26264399 | Derived | Jaiswal M, Martin CL, Brown MB, Callaghan B, Albers JW, Feldman EL, Pop-Busui R. Effects of exenatide on measures of diabetic neuropathy in subjects with type 2 diabetes: results from an 18-month proof-of-concept open-label randomized study. J Diabetes Complications. 2015 Nov-Dec;29(8):1287-94. doi: 10.1016/j.jdiacomp.2015.07.013. Epub 2015 Jul 17. |
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After obtaining written informed consent, participants were asked to provide medical history. A physical examination was performed, with specific focus on signs and symptoms of peripheral neuropathy. Baseline labs were obtained. Eligible subjects were invited for a baseline visit at which detailed neurologic assessment were done.
Date of first patient randomized to treatment:10/29/2008 Date of last patient randomized to treatment:12/07/2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide | Subjects will take exenatide by subcutaneous injection twice daily for 18 months Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels |
| FG001 | Glargine | Subjects will take 1 daily injection of insulin glargine for 18 months. Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide | Subjects will take exenatide by subcutaneous injection twice daily for 18 months Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels |
| BG001 |
| 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 | Confirmed Clinical Neuropathy (CCN) | CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude < 5 μV and a conduction velocity < 40 m/sec for the sural nerve and an amplitude < 2.5 μV and a conduction velocity < 40 m/sec for the peroneal nerve). | Posted | Number | participants | 18 Months |
|
From Screening to Study End: 1 year 7 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 | Exenatide | Subjects will take exenatide by subcutaneous injection twice daily for 18 months Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Serious Adverse Event | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rodica Pop-Busui, MD, PhD | University of Michigan | 734 647-9809 | rpbusui@med.umich.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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|
| Glargine | Drug | Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control |
|
|
| 18 month |
| Glargine |
Subjects will take 1 daily injection of insulin glargine for 18 months. Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Glargine | Subjects will take 1 daily injection of insulin glargine for 18 months. Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control |
|
|
| Secondary | Cardiac Autonomic Neuropathy (CAN) | Group differences in E/I ratio, a measure of cardiac autonomic function. | Posted | Mean | Standard Deviation | unit-less measure | 18 months |
|
|
|
| Secondary | Cardiac Autonomic Neuropathy | resting heart rate as marker of autonomic function at rest | Posted | Mean | Standard Deviation | beats per minute | 18 month |
|
|
|
| Other Pre-specified | Intra-epidermal Nerve Fiber Density | Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin. | Subset of study population | Posted | Mean | Standard Deviation | nerve fibers per mm of skin | 12 months |
|
|
|
| 6 |
| 22 |
| 9 |
| 22 |
| EG001 | Glargine | Subjects will take 1 daily injection of insulin glargine for 18 months. Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control | 8 | 24 | 19 | 24 |
| Coronary Artery Bypass Graft | Cardiac disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment | Exacerbation of existing congestive heart failure |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Status Asthmaticus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Pancreatic Neuroendocrine Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Pregnancy | Reproductive system and breast disorders | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Cholilithiasis | Gastrointestinal disorders | Systematic Assessment |
|
| Thyroidectomy | Endocrine disorders | Systematic Assessment |
|
| Non-ST elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Incarcerated Ventral Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| foot ulcer with cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Amputation of Toe | Musculoskeletal and connective tissue disorders | Systematic Assessment | because of persistent cellulitis and non-healing ulcers |
|
| Bone Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 c-spine fracture due to motor vehicle accident 1 lower leg fracture because of fall |
|
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment |
|
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| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |