NCT00334711

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
Last Updated

November 29, 2006

Status Verified

June 1, 2006

First QC Date

June 7, 2006

Last Update Submit

November 28, 2006

Conditions

Diabetes Mellitus

Keywords

Permanent Neonatal DiabetesKir6.2KCNJ11Infancy onset diabetesSulfonylurea

Outcome Measures

Primary Outcomes (1)

  • HbA1c reduction

Secondary Outcomes (4)

  • insulin secretory response to intravenous glucose

  • insulin secretory response to oral glucose

  • insulin secretory response to mixed meal (sustacal)

  • Incidence of Hypoglycemia

Interventions

SulfonylureaDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes due to KCNJ11 (Kir6.2) mutation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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, 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.

    PMID: 15115830BACKGROUND

  • 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.

    PMID: 16885550RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Andrew T Hattersley

    Peninsula Medical School, Exeter, UK

    STUDY DIRECTOR

  • Ewan R Pearson

    Peninsula Medical School, Exeter, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

January 1, 2004

Study Completion

January 1, 2006

Last Updated

November 29, 2006

Record last verified: 2006-06