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

This study has been completed.

First Received on May 2, 2006. Last Updated on October 1, 2008 History of Changes

Sponsor:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00321321

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Sulfonylurea	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

Insulin Secretion [ Time Frame: 0 - 90 minutes ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	May 2006
Study Completion Date:	April 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321321

Locations

Denmark
Department of Internal Medicine, Gentofte University Hospital
Hellerup, Copenhagen, Denmark, 2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

Principal Investigator:

Kasper Aaboe, M.D.

Gentofte University Hospital

More Information

No publications provided

Responsible Party:	Kasper Aaboe, Gentofte University Hospital
ClinicalTrials.gov Identifier:	NCT00321321 History of Changes
Other Study ID Numbers:	KA-05011
Study First Received:	May 2, 2006
Results First Received:	September 29, 2008
Last Updated:	October 1, 2008
Health Authority:	Denmark: Ethics Committee

Keywords provided by University Hospital, Gentofte, Copenhagen:

Type 2 diabetes mellitus
Glucose dependent insulinotropic polypeptide
Sulfonylurea compounds

insulin secretion
Sulfonylurea receptor subunit-SUR1
Impaired incretin effect

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastric Inhibitory Polypeptide
Incretins

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012