Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510093
• Other study ID #: 2011/1811
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2012
• Last updated: January 28, 2013
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin Aspart 100 IE/ml
1.5 IE/hour/subject/visit. Each vist takes 10 hours

Locations

Country	Name	City	State
Denmark	Department of Endocrinology and Internal Diseases	Aarhus C	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profiles of endogenous insulin and Insulin Aspart	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	10 hours	Yes
Secondary	Pharmacodynamic glucose profiles	Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .	10 hours	Yes