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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Sulfonylurea
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes mellitus, Glucose dependent insulinotropic polypeptide, Sulfonylurea compounds, insulin secretion, Sulfonylurea receptor subunit-SUR1, Impaired incretin effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine, Gentofte University Hospital

Outcomes

Primary Outcome Measures

Insulin Secretion
area under the curve AUC and insulin secretion rate

Secondary Outcome Measures

Full Information

First Posted
May 2, 2006
Last Updated
June 23, 2015
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00321321
Brief Title
The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes
Official Title
Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes mellitus, Glucose dependent insulinotropic polypeptide, Sulfonylurea compounds, insulin secretion, Sulfonylurea receptor subunit-SUR1, Impaired incretin effect

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sulfonylurea
Primary Outcome Measure Information:
Title
Insulin Secretion
Description
area under the curve AUC and insulin secretion rate
Time Frame
0 - 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasper Aaboe, M.D.
Organizational Affiliation
Gentofte University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Gentofte University Hospital
City
Hellerup, Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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