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Trial · Interventional

CompletedPhase 3Registry data

Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)

NCTNCT01020955 (opens ClinicalTrials.gov in a new tab)Other idGH/IGF-I
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
14 participants (actual)
Sponsor
Karolinska University Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

Sweden

Start
Oct 2009
Primary completion
Nov 2011
Completion
Nov 2011
First posted
26 Nov 2009 (estimated)
Last update posted
7 Apr 2015 (estimated)
Conditions
Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 3

    Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)

    NCT01020955

    Oct 2009 to Nov 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NutropinAq (GH) and Increlex (IGF-I)Drug
  • NutropinAq and placeboDrug

Arms2

  • Active comparator

    NutropinAq and Increlex

    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).

  • Placebo comparator

    NutropinAq and placebo

    NutropinAq (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and placebo for 6 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Insulin sensitivity

    Time frame · start and 6 months

Secondary outcomes(1)

  1. body composition

    Time frame · start and 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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. 2. Impaired glucose tolerance test or diabetes (stable on oral antidiabetic medication for at least 3 months) 3. HbA1C\<7.5% 4. Age 18-70 years 5. Each patient must sign an informed consent document before inclusion in the study 6. 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. \- Exclusion Criteria: 1. Known or suspected allergy to GH or IGF-I preparation 2. Insulin treatment 3. Proliferative retinopathy 4. Previous malignancy or other serious diseases (ex severe cardiovascular diseases, severe infections). Patients with a history of cancer can be included if they have been treated with curative therapy and have been disease free for more than 5 years. Patients with cardiac failure are not included. 5. Increased liver enzymes (ASAT or ALAT\>2.5 normal range) 6. S-creatinine above 120 umol/L 7. Patients with active hyperthyroidism and untreated hypothyroidism 8. Pregnancy 9. Lactation

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