NCT01020955

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Oct 2009

Typical duration for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

November 25, 2009

Last Update Submit

April 6, 2015

Conditions

Diabetes

Keywords

GH and IGF-Igrowth hormone deficiency and IGT or diabetes

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    start and 6 months

Secondary Outcomes (1)

  • body composition

    start and 6 months

Study Arms (2)

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).

Drug: NutropinAq (GH) and Increlex (IGF-I)

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.

Drug: NutropinAq and placebo

Interventions

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)

Also known as: NutropinAq (GH), Increlex (IGF-I)
NutropinAq and Increlex
NutropinAq and placeboDRUG

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

Also known as: NutropinAq (GH), Placebo
NutropinAq and placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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 have been 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, karolinska University hospital

Solna, Sweden, 171 76, Sweden

Location

MeSH Terms

Conditions

Diabetes MellitusDwarfism, Pituitary

Interventions

mecaserminInsulin-Like Growth Factor I

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological Factors

Study Officials

  • Charlotte Hoeybye, MD

    Karolinska UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 26, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

SE(1)