Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510093

Enrollment

Registered

2012-01-13

Start date

2012-05-31

Completion date

2013-01-31

Last updated

2013-01-29

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

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus, endogenous insulin

Brief summary

This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised. Hypotheses: 1. Secretion of endogenous insulin depends on exogenous insulin supply 2. Secretion of endogenous insulin is depends on plasma glucose levels

Detailed description

There are a screening visit and two treatment sessions: Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.

Interventions

DRUGInsulin Aspart 100 IE/ml

1.5 IE/hour/subject/visit. Each vist takes 10 hours

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Subjects with type 2 diabetes mellitus * Insulin-naive patients * HbA1C \< 9% * Women and men \>= 35 and \<= 75 years old * BMI 25-42 kg/m2, both values are included

Exclusion criteria

* Suspected or known allergy to the trial drug or similar medications * Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels * Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months * Severe uncontrolled hypertension with blood pressure in lying position \> 180/110 mmHg * Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory * Impaired kidney function with eGFR \< 50 ml/min according to the local laboratory * Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart	10 hours	Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose

Secondary

Measure	Time frame	Description
Pharmacodynamic glucose profiles	10 hours	Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026