GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes (GIP-HYPO-T2DM)

Mikkel Christensen

Status and phase: Completed; Early Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Glucose-dependent Insulinotropic polypeptide; Other: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01414556

H-2-2009-078

Details and patient eligibility

About

Investigation of GIP effects at fasting and hypoglycemia

Enrollment: 12 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion criteria

• HbA1c >9 %
• Liver disease (ALAT/ASAT >2 x upper normal limit)
• Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
• Proliferative diabetic retinopathy (anamnestic)
• Severe arteriosclerosis or heart failure (NYHA group III og IV)
• Anemia
• treatment with medication not applicable to pause for 12 hours
• Fasting plasma glucose >15 mM on screening day.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 3 patient groups

hyperglycemia

Experimental group

Treatment:

Other: saline

Other: Glucose-dependent Insulinotropic polypeptide

fasting glycemia

Experimental group

Treatment:

Other: saline

Other: Glucose-dependent Insulinotropic polypeptide

hypoglycemia

Experimental group

Treatment:

Other: saline

Other: Glucose-dependent Insulinotropic polypeptide