Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Placebo; Drug: glucose-dependent insulinotropic polypeptide

Study type: Interventional

Funder types: Other

Identifiers

NCT01048268

GIP HYPO (MC)

Details and patient eligibility

About

The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose

Full description

The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.

From this, we will evaluate GIP's role as blood sugar stabilizer.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
• Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
• Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
• Normal hemoglobin
• Informed consent

Exclusion criteria

• Unwillingness to participate or the wish to leave the present study
• HbA1c > 9 %
• Liver disease (ALAT or ASAT > 2 times normal value)
• Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
• Proliferative diabetic retinopathy (anamnetic)
• Atherosclerotic heart disease or heart failure (NYHA group III and IV)
• Anemia
• Treatment with medicine which cannot be paused for 12 hours
• Pregnancy and/or breast feeding
• Fasting plasma glucose > 15 mM on the day of the experiment

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 3 patient groups

Healthy volunteers

Experimental group

Treatment:

Drug: glucose-dependent insulinotropic polypeptide

Drug: Placebo

Patients with Type 1 diabetes mellitus

Experimental group

Treatment:

Drug: glucose-dependent insulinotropic polypeptide

Drug: Placebo

Patients with type 2 diabetes mellitus

Experimental group

Treatment:

Drug: glucose-dependent insulinotropic polypeptide

Drug: Placebo