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The aim of this study is to measure effects of the combined treatment with GH and IGF-I on glucose sensitivity and body composition in patients with GHD and IGT or diabetes.
The study was a 6 months randomised placebo controlled trial of adults with GHD and type 2 diabetes. All receive GH (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and are randomised to IGF-I or placebo (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months). Glucose metabolism is evaluated with euglycemic hyperinsulinemic clamp and body composition by computed tomography (CT) and bio impedance;.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NutropinAq and Increlex | Active Comparator | NutropinAq (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and Increlex (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months). |
|
| NutropinAq and placebo | Placebo Comparator | NutropinAq (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and placebo for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NutropinAq (GH) and Increlex (IGF-I) | Drug | NutropinAq (GH)(0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and Increlex (IGF-I) (15 µg/kg/d for 1 month, 30 µg/kg/d for 5 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | start and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| body composition | start and 6 months |
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Inclusion Criteria:
Verified profound GH deficiency. If the patient is already on GH replacement therapy this must have been commenced at least 6 months prior to study entry.
Impaired glucose tolerance test or diabetes (stable on oral antidiabetic medication for at least 3 months)
HbA1C<7.5%
Age 18-70 years
Each patient must sign an informed consent document before inclusion in the study
Women of childbearing potential must provide a negative pregnancy test before study start, and they must agree to use an effective method of contraception such as double barrier contraception, an injectable or implanted hormonal contraceptive, combined oral contraceptive or an intra-uterine device (IUD). The patient must agree to continue to use the contraceptive for two weeks after the last injection of IMP. Women without childbearing potential are defined as being postmenopausal for at least 1 year, or permanently sterilised at least 3 months before study entry.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Hoeybye, MD | Karolinska UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, karolinska University hospital | Solna | Sweden | 171 76 | Sweden |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000604197 | mecasermin |
| D007334 | Insulin-Like Growth Factor I |
| ID | Term |
|---|---|
| D013002 | Somatomedins |
| D000096764 | Insulin-Like Peptides |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| NutropinAq and placebo | Drug | NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months. |
|
|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |