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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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 August 01, 2014