Pilot Study Investigating the Feasibility of Determining the Endogenous Glucose Production During a Hypoglycaemia — PILOT_EGP  

Type 1 Diabetes Mellitus Clinical Trial

Official title: An Open, Non-randomized, Single-center Pilot Study Investigating the Feasibility of Determining the Endogenous Glucose Production During a Hypoglycaemic Clamp in Type 1 Diabetes Mellitus Subjects

Status Completed

Clinical Trial Summary

Primary objective is to investigate the feasibility and stability of determining the endogenous glucose production during a hypoglycaemic clamp in type 1 diabetes mellitus subjects by a stable tracer to tracee ratio with an enrichment of 4% and a variation below +/-30%.

Population: twenty type 1 diabetic subjects

Study design: Single-center, open, non- randomized, pilot-study

Clinical Trial Description

Each subject will participate on 3 Visits. The total study duration for each subject will be approximately one month.The trial can be divided into:

• Screening Visit (Visit 1)

• Hypoglycaemic clamp Visit (Visit 2)

• Follow up Visit (Visit 3)

Screening Visit (Visit1):

The subject will be asked to attend the screening visit fasting. The following data will be assessed and performed: informed consent signed and dated, inclusion and exclusion criteria for the study, a full medical history including current medication, physical examination and laboratory examination of blood/urine samples. For women in childbearing potential a urine pregnancy test will be performed.

Hypoglycaemic Visit (Visit2):

Each subject will be asked to attend the clinical unit at approximately 20:00 in the evening on day 1. Thereafter the subject will receive an insulin and glucose infusion intravenously in order to obtain a steady state of a PG level of 5.5 mmol/L overnight until approximately 08:00 in the morning of day 2. At 05:00 hours D-[6,6-2H2] glucose (100 g/l) solution will be given i.v. as a primed (9.6 mg/kg/min) for one minute and a constant (0.08 mg/kg/min) infusion until the last blood sampling of the plasma glucose level of 4.0 mmol/L will be performed.

At 08:00 hours in the morning at day 2, insulin infusion will be increased to 1.5 mU/kg/min for each subject and the Plasma Glucose will be kept at a plateau of 5.5 mmol/L by a controlled variable intravenous infusion of glucose (10% glucose enriched with 4mg [6,6-2H2] glucose /ml) for one hour. Afterwards, plasma glucose is allowed to fall to a plateau of 3.5 mmol/L, then to a nadir of 2.5 mmol/L, then to a blood glucose level of 4.0 mmol/L and finally back to a level of 5.5 mmol/L for safety reasons. Blood sampling for measurement of plasma glucose, [6,6-2H2] glucose (labelled glucose),glucagon, vital signs, hypoglycaemic symptoms questionnaire and hypoglycaemic awareness will be performed at each plasma glucose plateau. The subject will be discharged from the clinic at day 2, or later if deemed necessary by the investigator.

Follow up Visit (Visit 3):

The subject will attend the Visit 3, 3 - 10 days after Visit 2. The following data will be assessed and performed: concomitant medication, including current diabetes treatment, adverse events, a full physical examination and laboratory examination of blood/urine samples. For women in childbearing potential a urine pregnancy test will be performed. ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT02028078
• Study type: Interventional
• Source: Medical University of Graz
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Completion date: March 2016