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NCT00334711 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00334711
Other study ID # 2003/10/196
Secondary ID 97/29/AH/mbs NTN
Status Completed
Phase N/A
First received June 7, 2006
Last updated November 28, 2006
Start date January 2004
Est. completion date January 2006

Study information
Verified date June 2006
Source Royal Devon and Exeter NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diabetes due to KCNJ11 (Kir6.2) mutation

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sulfonylurea

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Royal Devon and Exeter NHS Foundation Trust Haukeland University Hospital, Hôpital Necker-Enfants Malades, Wellcome Trust

References & Publications (2)

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, Njølstad 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. — View Citation

Pearson ER, Flechtner I, Njølstad 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, Søvik O, Polak M, Hattersley AT; Neonatal Diabetes International Collabo — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c reduction
Secondary insulin secretory response to intravenous glucose
Secondary insulin secretory response to oral glucose
Secondary insulin secretory response to mixed meal (sustacal)
Secondary Incidence of Hypoglycemia
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