Insulin-like Growth Factor (IGF-I) induced muscle glucose uptake and interstitial IGF-1 concentrations. Placebo controlled, crossover study of the effect of sc rhIGF-I(Increlex) administration on glucose infusion rate (whole body glucose utilization) and interstitial muscle IGF-1 concentrations under euglycemic clamp conditions in T1DM adolescents and young adults - IGF-I induced muscle glucose uptake and interstitial IGF-I concentrations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000233-37-SE

Enrollment

Registered

2011-01-27

Start date

2011-04-05

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus MedDRA version: 12.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent

Interventions

Trade Name: Increlex 10mg/ml Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 1 diabetes duration at least two years and assumed C-peptide negativity 2. Chronological age from 16 to 25 years 3. Tanner stage > 4 (Girls: Tanner B4 or more, Boys: Testis > 15 ml) 4. Levemir or Lantus or Insulatard as basal analogue or CSII 5. IGF-1 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Development of hypoglycemia that can not be controlled with increased glucose infusion-rate

Design outcomes

Primary

Measure	Time frame
Main Objective: To validate the microdialysis technique as an useable tool to predict local biological effects of IGF-1 ;Secondary Objective: To understand the pharmacokinetics of local IGF-I actions after sc injection of Increlex in type 1 diabetic patients;Primary end point(s): Difference in microdialysis IGF-1 over time between saline and IGF-I injection. A 50% increase in local IGF-1 concentration is considered to be relevant.	—

Measure

Time frame

Main Objective: To validate the microdialysis technique as an useable tool to predict local biological effects of IGF-1 ;Secondary Objective: To understand the pharmacokinetics of local IGF-I actions after sc injection of Increlex in type 1 diabetic patients;Primary end point(s): Difference in microdialysis IGF-1 over time between saline and IGF-I injection. A 50% increase in local IGF-1 concentration is considered to be relevant.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026