Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations - Full Text View

Sponsors and Collaborators:	Royal Devon and Exeter NHS Foundation Trust Wellcome Trust Hôpital Necker-Enfants Malades Haukeland University Hospital
Information provided by:	Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00334711

Purpose

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.

Condition	Intervention
Diabetes Mellitus	Drug: Sulfonylurea

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations

Further study details as provided by Royal Devon and Exeter NHS Foundation Trust:

Primary Outcome Measures:

HbA1c reduction

Secondary Outcome Measures:

insulin secretory response to intravenous glucose
insulin secretory response to oral glucose
insulin secretory response to mixed meal (sustacal)
Incidence of Hypoglycemia

Estimated Enrollment:	50
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2006

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetes due to KCNJ11 (Kir6.2) mutation

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334711

Sponsors and Collaborators

Royal Devon and Exeter NHS Foundation Trust

Wellcome Trust

Hôpital Necker-Enfants Malades

Haukeland University Hospital

Investigators

Study Director:	Andrew T Hattersley	Peninsula Medical School, Exeter, UK
Principal Investigator:	Ewan R Pearson	Peninsula Medical School, Exeter, UK

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Other Publications:

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. Erratum in: N Engl J Med. 2004 Sep 30;351(14):1470.

Study ID Numbers:	2003/10/196, 97/29/AH/mbs NTNU, Jnr 207/mkd NTNU, CCPPRB Necker GLIDKIR6.2
Study First Received:	June 7, 2006
Last Updated:	November 28, 2006
ClinicalTrials.gov Identifier:	NCT00334711
Health Authority:	United Kingdom: National Health Service

Keywords provided by Royal Devon and Exeter NHS Foundation Trust:

Permanent Neonatal Diabetes
Kir6.2
KCNJ11
Infancy onset diabetes
Sulfonylurea

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009