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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 | Drug: NPH Drug: Detemir Drug: Glargine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: NPH insulin injection
NPH insulin will be injected in random order in one of three seperated visit days.
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Drug: NPH
equal doses of NPH insulin, insulin Detemir and insulin glargine injection
Other Name: NPH insulin: Insulatard |
Experimental: detemir insulin injection
insulin detemir will be injected in random order in one of three seperated visit days.
|
Drug: Detemir
equal doses of NPH insulin, insulin Detemir and insulin glargine injection
Other Name: insulin Detemir: Levemir |
Experimental: glargine insulin injection
insulin glargine will be injected in random order in one of three seperated visit days.
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Drug: Glargine
equal doses of NPH insulin, insulin Detemir and insulin glargine injection
Other Name: insulin glargine: Lamtus |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461616
Denmark | |
Department of Endocrinology and Internal Medicine, Aarhus University Hospital | |
Aarhus, Denmark, 8000 |
Principal Investigator: | Jens Sandahl Christiansen, M.D. | Department of Endocrinology and Internal Medicine, Aarhus University Hospital |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT01461616 |
Other Study ID Numbers: |
NPH-Detemir-Glargine-2011 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | December 4, 2012 |
Last Verified: | December 2012 |
Diabetes Mellitus, Type 1 |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin Insulin, Globin Zinc Insulin Glargine Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |