NCT00321321

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 2, 2008

Completed
Last Updated

July 16, 2015

Status Verified

September 1, 2008

Enrollment Period

10 months

First QC Date

May 2, 2006

Results QC Date

September 29, 2008

Last Update Submit

June 23, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitusGlucose dependent insulinotropic polypeptideSulfonylurea compoundsinsulin secretionSulfonylurea receptor subunit-SUR1Impaired incretin effect

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion

    area under the curve AUC and insulin secretion rate

    0 - 90 minutes

Interventions

SulfonylureaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \> BMI \> 40 kg/m2
  • Signed informed consent
  • Sufficient birth control in case of child bearing capacity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Gentofte University Hospital

Hellerup, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Results Point of Contact

Title
Dr. Kasper Aaboe
Organization
Gentofte Hospital, University of Copenhagen
Kasper@dadlnet.dk
+4539978474

Study Officials

  • Kasper Aaboe, M.D.

    Gentofte University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 3, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

July 16, 2015

Results First Posted

October 2, 2008

Record last verified: 2008-09

Locations

DK(1)