Status:
COMPLETED
Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis
Lead Sponsor:
University of Aarhus
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The objective is to describe the interaction of equal doses of NPH insulin (Neutral Protamine Hagedorn), insulin Detemir and insulin glargine on IGFBP-1 (Insulin-like Growth Factor Binding Protein-1) ...
Detailed Description
Because of the importance of receptors activation and potential effects on the IGF system, a head-to-head comparison of the eventual differential impact of intermediate-acting human insulin (NPH), ins...
Eligibility Criteria
Inclusion
- Informed consent obtained before any trial-related activities.
- Diagnosis of diabetes mellitus according to WHO criteria; history and clinical course consistent with type 1 diabetes mellitus.
- Diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (CSII) at least 6 months at time of inclusion.
- Total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
- HbA1c between 6% and 9% (both values included).
- Age ≥ 18 years.
- BMI between 18.5 and 28 kg /m2 (including both values).
Exclusion
- Known or suspected allergy to trial product(s) or related products.
- Recurrent major hypoglycaemic episodes.
- Heart: Unstable Angina Pectoris, AMI \< 12 months or heart insufficiency classified according to NYHA III-IV
- Blood Pressure: Severe uncontrolled hypertension with BP \> 180/110 mmHg, sitting
- Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase \> 2 x upper reference limit of the local laboratory.
- Kidneys: Impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory.
- Any disease judged by the investigator to affect the trial.
- Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01461616
Start Date
February 1 2012
End Date
November 1 2012
Last Update
December 4 2012
Active Locations (1)
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1
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Denmark, 8000