Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations

This study has been completed.

Sponsor:

Collaborators:

Wellcome Trust

Hôpital Necker-Enfants Malades

Haukeland University Hospital

Information provided by:

Royal Devon and Exeter NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT00334711

First received: June 7, 2006

Last updated: November 28, 2006

Last verified: June 2006

History of Changes

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines

U.S. FDA Resources

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

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.

ClinicalTrials.gov Identifier:	NCT00334711 History of Changes
Other 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
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

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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