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.
Sponsor:
University Hospital, Gentofte, Copenhagen
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00321321
First received: May 2, 2006
Last updated: October 1, 2008
Last verified: September 2008
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Results First Received: September 29, 2008
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic |
| Condition: |
Diabetes Mellitus, Type 2 |
| Intervention: |
Drug: Sulfonylurea |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| May 2006 - March 2007, Outpatient clinic and advertisement |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| none |
Reporting Groups
| Description | |
|---|---|
| Sulfonylurea | No text entered. |
Participant Flow: Overall Study
| Sulfonylurea | |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Sulfonylurea | No text entered. |
Baseline Measures
| Sulfonylurea | |
|---|---|
|
Number of Participants
[units: participants] |
12 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 1 |
|
Age
[units: years] Mean ± Standard Deviation |
55 ± 7.6 |
|
Gender
[units: participants] |
|
| Female | 4 |
| Male | 8 |
|
Region of Enrollment
[units: participants] |
|
| Denmark | 12 |
Outcome Measures
| 1. Primary: | Insulin Secretion [ Time Frame: 0 - 90 minutes ] |
Hide Outcome Measure 1| Measure Type | Primary |
|---|---|
| Measure Title | Insulin Secretion |
| Measure Description | area under the curve AUC and insulin secretion rate |
| Time Frame | 0 - 90 minutes |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Sulfonylurea | No text entered. |
Measured Values
| Sulfonylurea | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
12 |
|
Insulin Secretion
[units: pmol/l * 90 minutes] |
56766 |
No statistical analysis provided for Insulin Secretion
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Dr. Kasper Aaboe
Organization: Gentofte Hospital, University of Copenhagen
phone: +4539978474
e-mail: Kasper@dadlnet.dk
Organization: Gentofte Hospital, University of Copenhagen
phone: +4539978474
e-mail: Kasper@dadlnet.dk
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 |