Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations
November 28, 2006 updated by: Royal Devon and Exeter NHS Foundation Trust
A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations
The purpose of this study is to investigate whether patients with diabetes due to Kir6.2 mutations can be treated with sulfonylurea medication rather than insulin, and if this is the case to investigate the mechanism for sulfonylurea response.
Study Overview
Study Type
Interventional
Enrollment
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diabetes due to KCNJ11 (Kir6.2) mutation
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
HbA1c reduction
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
insulin secretory response to intravenous glucose
|
|
insulin secretory response to oral glucose
|
|
insulin secretory response to mixed meal (sustacal)
|
|
Incidence of Hypoglycemia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Andrew T Hattersley, Peninsula Medical School, Exeter, UK
- Principal Investigator: Ewan R Pearson, Peninsula Medical School, Exeter, UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pearson ER, Flechtner I, Njolstad PR, Malecki MT, Flanagan SE, Larkin B, Ashcroft FM, Klimes I, Codner E, Iotova V, Slingerland AS, Shield J, Robert JJ, Holst JJ, Clark PM, Ellard S, Sovik O, Polak M, Hattersley AT; Neonatal Diabetes International Collaborative Group. Switching from insulin to oral sulfonylureas in patients with diabetes due to Kir6.2 mutations. N Engl J Med. 2006 Aug 3;355(5):467-77. doi: 10.1056/NEJMoa061759.
- Gloyn AL, Pearson ER, Antcliff JF, Proks P, Bruining GJ, Slingerland AS, Howard N, Srinivasan S, Silva JM, Molnes J, Edghill EL, Frayling TM, Temple IK, Mackay D, Shield JP, Sumnik Z, van Rhijn A, Wales JK, Clark P, Gorman S, Aisenberg J, Ellard S, Njolstad PR, Ashcroft FM, Hattersley AT. Activating mutations in the gene encoding the ATP-sensitive potassium-channel subunit Kir6.2 and permanent neonatal diabetes. N Engl J Med. 2004 Apr 29;350(18):1838-49. doi: 10.1056/NEJMoa032922. Erratum In: N Engl J Med. 2004 Sep 30;351(14):1470.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion
January 1, 2006
Study Registration Dates
First Submitted
June 7, 2006
First Submitted That Met QC Criteria
June 7, 2006
First Posted (Estimate)
June 8, 2006
Study Record Updates
Last Update Posted (Estimate)
November 29, 2006
Last Update Submitted That Met QC Criteria
November 28, 2006
Last Verified
June 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003/10/196
- 97/29/AH/mbs NTNU
- Jnr 207/mkd NTNU
- CCPPRB Necker GLIDKIR6.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.