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

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00321321
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Sulfonylurea	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Insulin Secretion [0 - 90 minutes]

   area under the curve AUC and insulin secretion rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00321321
• Other Study ID Numbers: KA-05011
• First Posted: May 3, 2006
• Last Update Posted: Jul 16, 2015
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: 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

Study Results

Participant Flow

Recruitment Details	May 2006 - March 2007, Outpatient clinic and advertisement

Arm/Group Title	Sulfonylurea
Arm/Group Description
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sulfonylurea
Arm/Group Description
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 91.7%
>=65 years	1 8.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (7.6)
Sex: Female, Male (Count of Participants)
Female	4 33.3%
Male	8 66.7%
Region of Enrollment (participants) [Number]
Denmark	12 100%

Outcome Measures

1. Primary Outcome

Title	Insulin Secretion
Description	area under the curve AUC and insulin secretion rate
Time Frame	0 - 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfonylurea
Arm/Group Description
Measure Participants	12
Number [pmol/l * 90 minutes]	56766

Adverse Events

Arm/Group Title	Sulfonylurea
Arm/Group Description	Sulfonylurea-treated patients
All Cause Mortality
	Sulfonylurea
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sulfonylurea
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Sulfonylurea
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.