Phase
Condition
Diabetic Macular Edema
Diabetic Kidney Disease
Diabetic Foot Ulcers
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Verified profound GH deficiency. If the patient is already on GH replacement therapythis must have been commenced at least 6 months prior to study entry.
Impaired glucose tolerance test or diabetes (stable on oral antidiabetic medicationfor 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 studystart, and they must agree to use an effective method of contraception such as doublebarrier contraception, an injectable or implanted hormonal contraceptive, combinedoral contraceptive or an intra-uterine device (IUD). The patient must agree tocontinue to use the contraceptive for two weeks after the last injection of IMP. Womenwithout childbearing potential are defined as being postmenopausal for at least 1year, or permanently sterilised at least 3 months before study entry.
Exclusion
Exclusion Criteria:
Known or suspected allergy to GH or IGF-I preparation
Insulin treatment
Proliferative retinopathy
Previous malignancy or other serious diseases (ex severe cardiovascular diseases,severe infections). Patients with a history of cancer can be included if they havebeen treated with curative therapy and have been disease free for more than 5 years.Patients with cardiac failure are not included.
Increased liver enzymes (ASAT or ALAT>2.5 normal range)
S-creatinine above 120 umol/L
Patients with active hyperthyroidism and untreated hypothyroidism
Pregnancy
Lactation
Study Design
Study Description
Connect with a study center
Department of Endocrinology, karolinska University hospital
Solna, 171 76
SwedenSite Not Available
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