The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes

The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Internal Medicine, Gentofte University Hospital

Hellerup, Copenhagen, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 diabetes mellitus diagnosed according to WHO criteria
Diet and/or metformin treatment
HbA1c > 7,0% for metformin treated patients
HbA1c > 7,5% for diet treated patients
Age: 18 years or older
25 > BMI > 40 kg/m2
Signed informed consent
Sufficient birth control in case of child bearing capacity

Exclusion criteria

Proliferative retinopathy
Diabetic nephropathy with s-creatinine > 130 microM and/or macroalbuminuria
Liver disease (ALAT > 2 x normal value)
CAD (NYHA group III or IV)
Positive screening for islet-cell and/or GAD-65 autoantibodies
Type 1 diabetes i first degree relatives
Gastrointestinal surgery with intestinal resection
Anemia
Pregnancy and/or breastfeeding

Treatment and study plan

Sulfonylurea

Drug

Primary outcomes

Insulin Secretion

Time frame: 0 - 90 minutes

area under the curve AUC and insulin secretion rate

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: May 3, 2006
Registry last updated: Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed