Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes

Steno Diabetes Centers

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Saline Solution; Drug: Glucose-Dependent Insulin-Releasing Hormone[3-30]; Drug: glucose-dependent insulinotropic peptide

Study type: Interventional

Funder types: Other

Identifiers

NCT03556098

H-18002707

Details and patient eligibility

About

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Caucasian men
• Body mass index between 20-27 kg/m^2
• T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c<69 mmol/l (<8,5%)
• T1D duration between 2-20 years
• Stimulated C-peptide ≤ 100 pmol/mL)
• Treatment with a stable basal bolus or insulin pump regimen ≥ 3 months
• Informed consent

Exclusion criteria

• Anemia (hemoglobin below normal range)
• Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder
• Nephropathy (serum creatinine above normal range and/or albuminuria)
• Allergy or intolerance to ingredients included in the standardized meals
• Prior myocardial infarction or other cardiac events
• Any physical or psychological condition that the investigator fells would interfere with trial participation
• Treatment with any glucose-lowering drugs beside insulin

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups, including a placebo group

GIP

Active Comparator group

Description:

Infusion of Glucose-dependent insulinotropic peptide

Treatment:

Drug: glucose-dependent insulinotropic peptide

GIP[3-30]

Active Comparator group

Description:

Infusion of GIP\[3-30\]

Treatment:

Drug: Glucose-Dependent Insulin-Releasing Hormone[3-30]

Saline

Placebo Comparator group

Description:

Infusion of saline

Treatment:

Drug: Saline Solution