Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Aarhus University Hospital

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Aspart 100 IE/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01510093

2011/1811

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Insulin Aspart without glucose supply

Other group

Description:

Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply

Treatment:

Drug: Insulin Aspart 100 IE/ml

Insulin Aspart with glucose supply

Other group

Description:

Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply

Treatment:

Drug: Insulin Aspart 100 IE/ml