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CLINICAL TRIALS PROFILE FOR INSULIN RECOMBINANT HUMAN
505(b)(2) Clinical Trials for Insulin Recombinant Human
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Combination | NCT00151697 ↗ | LANN-study: Lantus, Amaryl, Novorapid, Novomix Study | Completed | Rijnstate Hospital | Phase 3 | 2005-05-01 | Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments. |
| OTC | NCT00169299 ↗ | Herbal Alternatives for Menopause Symptoms (HALT Study) | Unknown status | National Center for Complementary and Integrative Health (NCCIH) | Phase 4 | 2001-06-01 | Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting. |
| OTC | NCT00169299 ↗ | Herbal Alternatives for Menopause Symptoms (HALT Study) | Unknown status | National Institute on Aging (NIA) | Phase 4 | 2001-06-01 | Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting. |
| OTC | NCT00169299 ↗ | Herbal Alternatives for Menopause Symptoms (HALT Study) | Unknown status | Group Health Cooperative | Phase 4 | 2001-06-01 | Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting. |
| New Combination | NCT00501709 ↗ | Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus | Active, not recruiting | Juvenile Diabetes Research Foundation | Phase 1/Phase 2 | 2004-02-01 | Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection. |
| New Combination | NCT00501709 ↗ | Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus | Active, not recruiting | University of California, San Francisco | Phase 1/Phase 2 | 2004-02-01 | Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection. |
| New Formulation | NCT00627796 ↗ | Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly | Completed | University of Genova | Phase 4 | 2003-01-01 | Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Insulin Recombinant Human
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000110 ↗ | Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA | Completed | National Center for Research Resources (NCRR) | N/A | 1969-12-31 | The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity. |
| NCT00000159 ↗ | Sorbinil Retinopathy Trial (SRT) | Completed | National Eye Institute (NEI) | Phase 3 | 1983-08-01 | To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes. |
| NCT00000380 ↗ | Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances | Completed | National Institute of Mental Health (NIMH) | N/A | 1996-06-01 | The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women). |
| NCT00000380 ↗ | Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances | Completed | University of Washington | N/A | 1996-06-01 | The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women). |
| NCT00000466 ↗ | Postmenopausal Estrogen/Progestin Interventions (PEPI) | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 3 | 1987-09-01 | To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation. |
| NCT00000466 ↗ | Postmenopausal Estrogen/Progestin Interventions (PEPI) | Completed | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Phase 3 | 1987-09-01 | To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation. |
| NCT00000466 ↗ | Postmenopausal Estrogen/Progestin Interventions (PEPI) | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 3 | 1987-09-01 | To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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