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Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis

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ClinicalTrials.gov Identifier: NCT01461616
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE October 24, 2011
First Posted Date  ICMJE October 28, 2011
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • IGF-I(ng/ml) [ Time Frame: 16 hours (from 18:00 to 10:00 next day) ]
    Hourly samples will be taken from 18:00 to 10:00 next day.
  • IGFBP-1(ng/ml) [ Time Frame: 16 hours (from 18:00 to 10:00 next day) ]
    Hourly samples will be taken from 18:00 to 10:00 next day.
  • IGFBP-2(ng/ml) [ Time Frame: 16 hours (from 18:00 to 10:00 next day) ]
    Hourly samples will be taken from 18:00 to 10:00 next day.
  • IGFBP-3(ng/ml) [ Time Frame: 16 hours (from 18:00 to 10:00 next day) ]
    Hourly samples will be taken from 18:00 to 10:00 next day.
  • Growth Hormone(ng/ml) [ Time Frame: 16 hours (from 18:00 to 10:00 next day) ]
    Hourly samples will be taken from 18:00 to 10:00 next day.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • plasma glucose concentration (mmol/L) after a single injection of either NPH insulin, insulin Detemir or insulin glargine [ Time Frame: 16 hours (from 18:00 to 10:00 next day) ]
    Hourly samples will be taken from 18:00 to 10:00 next day.
  • insulin concentration (mmol/L) after a single injection of either NPH insulin, insulin Detemir or insulin glargine [ Time Frame: 16 hours (from 18:00 to 10:00 next day) ]
    Hourly samples will be taken from 18:00 to 10:00 next day.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis
Official Title  ICMJE Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on IGFBP-1 Production and Serum IGF-I in Subjects With Type 1 Diabetes Mellitus: An Open-label, Randomised, Triple Cross-over Trial
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) production as well as immunoreactive and bioactive IGF-I (Insulin-like Growth Factor-I) after once-daily injection on three separate visits in type 1 diabetic subjects.
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), insulin detemir and insulin glargine on the growth hormone-insulin-like growth factor-insulin-like growth factor binding protein (GH-IGF-IGFBP) axis is relevant to be conducted for the safety assurance of insulin analogues. Therefore, this study aims to investigate whether the serum insulin profile obtained by once-daily injection of long-acting insulin analog, insulin detemir or insulin glargine, has a different impact on IGFBPs production and IGF-I concentrations (total IGF-I) bioactivity and tissue-availability as compared to that seen during treatment with intermediate-acting human insulin, NPH insulin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: NPH
    equal doses of NPH insulin, insulin Detemir and insulin glargine injection
    Other Name: NPH insulin: Insulatard
  • Drug: Detemir
    equal doses of NPH insulin, insulin Detemir and insulin glargine injection
    Other Name: insulin Detemir: Levemir
  • Drug: Glargine
    equal doses of NPH insulin, insulin Detemir and insulin glargine injection
    Other Name: insulin glargine: Lamtus
Study Arms  ICMJE
  • Experimental: NPH insulin injection
    NPH insulin will be injected in random order in one of three seperated visit days.
    Intervention: Drug: NPH
  • Experimental: detemir insulin injection
    insulin detemir will be injected in random order in one of three seperated visit days.
    Intervention: Drug: Detemir
  • Experimental: glargine insulin injection
    insulin glargine will be injected in random order in one of three seperated visit days.
    Intervention: Drug: Glargine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
16
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent obtained before any trial-related activities.
  2. Diagnosis of diabetes mellitus according to WHO criteria; history and clinical course consistent with type 1 diabetes mellitus.
  3. Diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (CSII) at least 6 months at time of inclusion.
  4. Total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
  5. HbA1c between 6% and 9% (both values included).
  6. Age ≥ 18 years.
  7. BMI between 18.5 and 28 kg /m2 (including both values).

Exclusion Criteria:

  1. Known or suspected allergy to trial product(s) or related products.
  2. Recurrent major hypoglycaemic episodes.
  3. Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
  4. Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
  5. Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
  6. Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
  7. Any disease judged by the investigator to affect the trial.
  8. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461616
Other Study ID Numbers  ICMJE NPH-Detemir-Glargine-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jens Sandahl Christiansen, M.D. Department of Endocrinology and Internal Medicine, Aarhus University Hospital
PRS Account University of Aarhus
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP