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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: glucose-dependent insulinotropic polypeptide; Drug: Placebo

• Registration Number: NCT01048268
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	glucose-dependent insulinotropic polypeptide	-
Patients with type 2 diabetes mellitus	glucose-dependent insulinotropic polypeptide	-
Patients with Type 1 diabetes mellitus	Placebo	-
Healthy volunteers	Placebo	-
Patients with type 2 diabetes mellitus	Placebo	-
Patients with Type 1 diabetes mellitus	glucose-dependent insulinotropic polypeptide	-

Primary Outcome Measures

Name	Time	Method
The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon	-10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit

Secondary Outcome Measures

Name	Time	Method
The difference between the amount of infused glucose and the insulin responses	will be measured at each visit

Trial Locations

Locations (1)

Department of Internal Medicine F' laboratory; 🇩🇰 Hellerup, Copenhagen County, Denmark